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Ventilators, Intensive Care

Scope of this Product Comparison

This Product Comparison covers positive-pressure ventilators designed for use in critical care settings. Although some of the models listed in the chart may have high-frequency ventilation capabilities, units that produce only high-frequency ventilation are not covered, nor are dedicated neonatal/pediatric ventilators, transport ventilators, anesthesia ventilators, or ventilators designed exclusively for home care. For information on these types of ventilators, see the following Product Comparisons: Anesthesia Units Ventilators, Intensive Care, Neonatal/Pediatric Ventilators, Portable/Home Care Ventilators, Transport These devices are also called: critical care ventilators, continuous ventilators, positive-pressure ventilators.

Purpose

Ventilators provide temporary ventilatory support or respiratory assistance to patients who cannot breathe on their own or who require assistance to maintain adequate ventilation because of illness, trauma, congenital defects, or drugs (e.g., anesthetics). In most mechanical ventilators, a positive-pressure source delivers gas to the patient's lungs to support gas exchange; to open or maintain ventilation of alveoli, where gas exchange occurs; and to rest ventilatory muscles until the patient is able to safely resume adequate spontaneous ventilation. Positive-pressure breaths are typically delivered through an endotracheal tube or a tracheostomy tube. The pressure in the lungs increases in proportion to the volume of inflating gas. The pressure is relieved as gas is exhaled through an exhalation pathway. A high-frequency ventilator uses positive pressure to deliver breaths at frequencies much higher than the normal breathing rate (e.g., >100 breaths/min). High-frequency ventilators were developed in an effort to reduce barotrauma and some of the deleterious hemodynamic effects associated with the high tidal volumes and positive pressure used with conventional ventilators. These ventilators are available for patients who cannot tolerate the airway pressures needed for ventilation at typical volumes; they may also be used when a motionless field is required for surgery near the UMDNS Information airways.

Principles of operation

A critical care ventilator (see Figure 1) typically consists of a flexible breathing circuit, a control system, a gas supply, and monitors and

This Product Comparison covers the following device term and product code as listed in ECRI Institute's Universal Medical Device Nomenclature SystemTM (UMDNSTM): Ventilators, Intensive Care [17-429]

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Ventilators, Intensive Care

alarms. Heating and humidification devices are available as add-on components. Most ventilators are microprocessor controlled and regulate the pressure, volume, or flow of the delivered positive-pressure breath, as well as the fraction of inspired oxygen (FiO2), based on control settings. Communications interfaces are also typically included so that information on control settings, monitored variables, and alarm status can be transferred to a bedside monitor, an information system, or some other interfaced device. Power is supplied from either an electrical wall outlet or a battery; battery power is used for short-term ventilation, such as during intrahospital patient transport. Some intensive care ventilators can receive gas (both air and oxygen [O2]) from a wall outlet that generally provides gas at a pressure of approximately 50 pounds per square inch (psi); the flow of gas to the Figure 1. A typical ventilator system patient can be regulated by flow-control valves on the ventilator. To obtain the desired FiO2 for delivery to the patient, most ventilators mix air and O2 internally. During inspiratory gas delivery, an exhalation valve is closed to maintain pressure in the breathing circuit and lungs. The gas is delivered to the patient through the flexible breathing circuit. Most intensive care ventilators use a double-limb breathing circuit made of corrugated plastic tubing to transport the gas from the ventilator to the patient through one limb (referred to as the inspiratory limb) and return the exhaled gas to the ventilator through the other limbs (referred to as the expiratory limb). During inspiratory gas delivery, the exhalation valve is closed to maintain pressure in the breathing circuit and lungs. After the inspiratory phase, the gas is released to ambient air through this valve. The breathing circuit also provides sites where the delivered gas may be heated; humidified; monitored for proximal airway pressure; and conditioned with nebulized medications, as well as where condensation may be collected. Many models have sensors within the ventilator or breathing circuit that can measure airway pressure or flow and provide feedback to the ventilator to automatically adjust its output.

Controls

Controls are used to select breathing mode and ventilation pattern parameters (e.g., tidal volume, breathing rate). For the ventilator to produce a prescribed breathing pattern, several parameters can be independently set, such as length of the inspiratory or expiratory phase, rate of mechanical breaths, ratio of inspiratory time to expiratory time (I:E ratio), waveform shape, tidal volume, minute volume (the volume inhaled in one minute), peak inspiratory flow, peak pressure, and positive end-expiratory pressure (PEEP). Intensive care ventilators have continuous positive airway pressure (CPAP) and PEEP controls, which are regulated by a restriction of flow to the exhalation valve. CPAP provides a constant pressure in the breathing circuit as the patient breathes spontaneously. This keeps the alveoli and airways inflated by preventing proximal airway pressure from returning to zero at the end of exhalation. CPAP is applied to patients who can breathe spontaneously and do not require full ventilatory support. It can improve lung volume and, consequently, oxygenation and lung function by increasing alveolar volumes, recruitment, and stability. By helping to redistribute interstitial water, CPAP also improves O2 diffusion across the alveolar capillary membrane. CPAP may be used to raise the PaO2 (patient's arterial partial pressure of oxygen) without requiring an increase in the FiO2. PEEP maintains a positive airway pressure from the end of an assisted, controlled, spontaneous, or mandatory exhalation to the beginning of the next inspiration. The result is similar to that obtained with CPAP

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and is achieved by restricting or prohibiting the exhalation of gases through the exhalation valve after the pressure has dropped to a prescribed value. PEEP aids in maintaining lung volume and in preventing alveolar collapse. Increases in PEEP are often used to increase the patient's arterial O 2 saturation without increasing the inspired O2 percentage, although very high PEEP may decrease venous return, cardiac output, and O2 transport and increase pulmonary vascular resistance. The I:E ratio is an indication of the partitioning of a breath into inspiration and expiration. In general, the expiratory time is set to be longer than the inspiratory time (e.g., I:E ratio is 1:2); however, an inverse ratio can also be used so that the inspiratory time exceeds the expiratory time (e.g., I:E ratio is 1:0.5). Because inverse I:E settings are not normally used, some ventilators signal when an inverse I:E ratio has been reached; others will not deliver inverse I:E breaths. Controls are also available for setting the flow waveform. Volume-controlled ventilation flow generally has square, accelerating, decelerating, or sinusoidal waveforms. Pressure ramp adjustments are now available in pressure-controlled ventilation modes. Such adjustments allow the user to maximize the flow and pressure levels while maintaining a flow delivery that lowers the work of breathing and is more comfortable for the patient.

Operating modes

Intensive care ventilators have several operating modes; a mode of operation defines the algorithm that will be used to initiate (or trigger) and end (or cycle) a machine breath. Different modes can provide either full or partial ventilatory support, depending on the individual patient's condition and respiratory ability. The control mode provides full support to patients who cannot breathe for themselves; it is infrequently used. In this mode, the ventilator provides mandatory breaths at preset time intervals and does not allow the patient to breathe spontaneously. This mode requires the patient to be unconscious or sedated to stop spontaneous attempts to breathe asynchronously with the ventilator. Assist/control modes also provide full support by delivering an assisted breath whenever the ventilator senses a patient's inspiratory effort and by delivering mandatory breaths at preset time intervals. This mode is designed for patients who have difficulty breathing but can initiate inspiration. A breath is triggered when a patient's breathing efforts are detected as a drop in pressure in the breathing circuit (pressure triggering) or as a difference in flow between the circuit's inspiratory and expiratory limbs (flow triggering). Most intensive care ventilators can deliver volume- and pressure-controlled breaths that can be used to provide both full and partial ventilatory support. With volume-controlled breaths, a control system is used to ensure that a set tidal volume is delivered during the inspiratory cycle. The set volume may not be delivered if the pressure exceeds the setting of the high-pressure alarm or of a pressure-relief valve. These modes are typically used for adult and pediatric patients to maintain adequate pulmonary gas exchange. Pressure-controlled breaths regulate flow delivery to attain and sustain a clinician-set inspiratory pressure level for a set time so that the ventilator delivers controlled or assisted breaths that are time cycled. Combination modes, which are now available on most models (although different ventilator vendors use different terminology), deliver pressurecontrolled breaths that correspond to a target tidal volume. In combination mode, the ventilator begins at a low inspiratory pressure level which is incrementally increased from breath to breath until the target tidal volume is achieved. The ventilator then maintains that inspiratory pressure unless changes in the patient's airway parameters (i.e., lung resistance and compliance) necessitate adjustments. These modes may allow more effective ventilation of patients whose lung characteristics change frequently.

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The synchronized intermittent mandatory ventilation (SIMV) mode delivers controlled breaths at a set frequency and also allows the patient to breathe spontaneously with no assistance during the periods between the controlled breaths. The mandatory breaths in this mode are synchronized with a spontaneous breathing effort if that effort occurs sufficiently close to the time the mandatory breath would have been produced. This reduces the possibility of overinflation, which could result from stacking a mandatory breath on a spontaneous breath. Another mode of ventilation is airway-pressure-release ventilation (APRV). APRV may be used to treat acute lung injury in patients who require mechanical support. The clinician sets a high and low pressure level as well as time at each pressure level (with the time at low pressure typically being very short). The ventilator switches between the two pressure levels at the set intervals while allowing the patient to breathe spontaneously at either level. Once an appropriate level of CPAP is selected, APRV is initiated whenever mechanical assistance is required by cyclically releasing the airway pressure until a lower level is obtained. Carbon dioxide exits the lungs passively as the airway pressure decreases. When this brief release period ends, the airway pressure rapidly returns to the CPAP level. This mode provides mechanical ventilatory assistance without raising the airway pressure above the CPAP level; consequently, barotrauma and adverse hemodynamic effects may occur less frequently than with other conventional modes of mechanical ventilation. Pressure support reduces the work of spontaneous breathing by delivering a preset level of positive pressure to the patient's airway during a spontaneous inspiratory effort. This reduces the work of the patient's respiratory muscles and minimizes the effort needed to draw an adequate amount of air into the lungs. It also compensates for the extra work of breathing imposed by the ventilator tubing and valves. Pressure support is an adjunct that may be added to spontaneous efforts in the SIMV and CPAP modes. A few manufacturers offer unique modes that deliver support to the patient based on the amount of effort (as opposed to pressure support where the level of support is static). One vendor offers proportional assist ventilation (PAV), in which the level of support is proportional to the patient's demand based on applying a specialized software algorithm to traditional flow and pressure measurements. In PAV, the clinician is guided to change support settings to keep the patient's work of breathing within a comfort zone calculated by the ventilator. Another vendor offers neurally adjusted ventilatory assist (NAVA), in which the patient's effort is determined by measuring the electrical activity in the diaphragm. The clinician selects a level of support, which serves as a multiplier to the electrical signal to determine the amount of flow to deliver to the patient.

Monitors and alarms

Intensive care ventilators are equipped with a variety of monitors and alarms to detect equipment-related problems and changes in patient status, to ensure that the user adjusts settings to achieve effective ventilation, and to reduce the risk of ventilator-induced injury (e.g., barotrauma). Variables that are typically monitored and displayed on the ventilator include the following: A continuous indication of airway pressure, as well as peak, mean, and baseline pressures Mechanical and spontaneous respiratory rates I:E ratio O2 concentration Exhaled volumes of mechanical and spontaneous breaths (tidal volumes) and accumulated volume over one minute (exhaled minute volume) Graphics monitors include graphs of pressure, volume, and flow versus time. To track the patient's progress, the monitor calculates patient pulmonary mechanics (e.g., compliance, resistance) from monitored variables. Pressure-volume loops, which are graphs of pressure versus volume over a single breath, and flow-volume loops, which are graphs of flow versus volume over a single breath, indicate breathing abnormalities such as obstructive or restrictive lung disease. Graphics monitors are generally part of the ventilator unit. If not, the manufacturer usually sells one with the unit. Graphics monitors allow the clinician to optimize ventilator setting values and assist with diagnostics. The

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displayed loops and lung mechanics parameters can also help clinicians recognize obstructive or restrictive flow patterns. Because the consequences of incorrect or inadequate mechanical ventilation can be severe, ventilators are equipped with audible and visual alarms to notify clinicians of changes in the patient's condition or of device problems. Most ventilators have alarms for apnea, high and low respiratory rate, high and low pressure, loss of power, loss of high-pressure gas, system malfunction, incorrect O2 concentration, and exhaled volume. Some ventilators also have baseline-pressure alarms; the low-baseline-pressure alarm alerts clinicians to losses of PEEP, which can affect the patient's O2 saturation, and the high-baseline-pressure alarm alerts clinicians to inadvertent increases in PEEP, which can prevent complete exhalation. An alarm should also be activated if disconnections occur in the breathing circuit or if flow resistance is encountered. A loss of power or of the gas supply, or other conditions affecting a ventilator's ability to operate, should produce an alarm and allow the patient to spontaneously breathe air or the specified gas mixture. All critical alarms should be easy to identify and impossible to disarm indefinitely. Additionally, to prevent injury to the patient until clinicians can respond to alarms, ventilators incorporate a number of safety features such as the capability to release pressure at the level of the high-pressure alarm setting. Another feature is the capability to provide backup ventilation, in which the ventilator will initiate breaths when it senses that the patient's breathing efforts have ceased.

Alarm-enhancement systems

Ventilator alarms are crucial for safeguarding the health and lives of patients. Therefore, it is vital that they be readily detected in even the busiest, noisiest hospital departments. Alarm-enhancement systems, which communicate ventilator alarms to locations where they are more likely to be detected by caregivers, can be helpful. There are four basic categories of ventilator alarm enhancements: Interfacing ventilators with physiologic monitors Incorporating commercially available systems for centralized monitoring of ventilator alarms Interfacing ventilators with nurse call systems Utilizing remote annunciators for ventilator alarms The various alarm-enhancement options range widely in complexity, cost, and the types of care settings for which they are likely to be suitable. For more information on alarm-enhancement systems and ventilatorphysiologic monitoring system interfaces, see ECRI Institute's Health Devices citation in the bibliography of this report.

Communication interfaces

Most intensive care ventilators have a standard or optional interface through which the ventilator can be connected to a bedside monitor or information system. Ventilator settings, monitored variables, and information on alarms can be transmitted through this interface. On some units, the interface can connect two ventilators, synchronizing them so that they can independently ventilate both lungs (e.g., for a patient with unilateral lung disease).

Reported problems

The most common problem associated with intensive care ventilators is the risk of a patient acquiring ventilator-associated pneumonia (VAP). It is generally accepted that prolonged ventilation periods greatly increase a patient's risk of acquiring VAP. The link between prolonged ventilation and VAP is unclear, but following proper infection control procedures in maintaining the ventilator, the breathing circuit, and all associated equipment can minimize patient risk.

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Leaks in the breathing circuit or components may prevent the ventilator from delivering a preset tidal volume or accurately sensing flow and terminating a pressure-supported breath. Also, such leaks can affect the ventilator's ability to maintain the PEEP level. This in turn may affect O 2 saturation and can result in autocycling. The friction-fit connector that attaches a ventilator to a patient's artificial airway can be accidentally disconnected if it is not attached securely by the clinician. Ventilators should signal an audible and visual alarm when they detect a leak or disconnection; however, some low-pressure alarms can be inappropriately adjusted below the detection threshold. Patient-ventilator dyssynchrony refers to the situation in which a mechanically ventilated patient fails to trigger the ventilator, or the ventilator erroneously senses a patient's effort and delivers breaths. The result is a machine breath rate that is inappropriate to the rate of the patient's inspiratory efforts. This is also called trigger failure or desynchronization, mismatching, and "fighting the ventilator." One cause for patient-ventilator dyssynchrony is improper setting of trigger sensitivity. The use of airway pressure and flow waveforms to detect it may not be reliable, since airway pressure and flow measured at the ventilator can be affected by various artifacts (e.g., hiccups, coughs, sudden displacement or compression of the ventilator tubing). Clinical observation is highly specific in identifying patient-ventilator dyssynchrony, since observation of thoracoabdominal movement has been the standard method of determining respiratory rate, and patients with patient-ventilator dyssynchrony often have heightened and prominent accessory muscle activity associated with inspiratory efforts. When gas delivery is not synchronized with the patient's efforts to initiate a breath, increased patient discomfort and work of breathing can result. This can also lead to respiratory distress, can inhibit pulmonary gas exchange, and can make weaning the patient from mechanical ventilation more difficult. Because in many cases the patient depends entirely on the ventilator for life support, ensuring proper maintenance and avoiding operator errors or machine failures can be critical. Some of the unavoidable risks of mechanical ventilation are barotrauma (when an airway pressure that is too high damages the lungs), reduced cardiac output, and adverse effects on gas exchange in the lungs. By using a well-designed ventilator and ensuring that it is set up and operated correctly, users can often prevent injury to the patient. In addition, ventilators are typically inspected at least semiannually, and operation is usually verified (or should be) before each use. These procedures should result in the detection of most cases of inappropriate setup or mechanical problems.

Purchase considerations

ECRI Institute recommendations

Included in the accompanying comparison chart are ECRI Institute's recommendations for minimum performance requirements for intensive care ventilators. The requirements are separated into two categories-- basic and mid/high complexity. The differences between these two categories are based on performance criteria for operating modes, controls, monitored parameters, and alarm functionality. The ventilator should offer assist/control and SIMV modes. For volume- and pressure-controlled breaths, it should also provide CPAP/PEEP and pressure support. The unit should monitor airway pressure, respiratory rate, I:E ratio, and minute volume; controls should be available for pressure level, tidal volume, breath rate, inspiratory time, FiO2, PEEP/CPAP, I:E ratio, pressure support, and sensitivity. ECRI Institute recommends that these units have patient-responsive features and patient-responsive modes or combination modes. For higher-end ventilators, graphical displays should include waveforms and loops. Loops should be saved for comparisons and trending of monitored variables. The higher-end units should also offer some respiratory maneuvers (e.g., PO. 1). Alarms, both visual and auditory, should be available for inspiratory pressure (low and high), low CPAP/PEEP, minute volume (low or low/high), respiratory rate (low and high), gas supply loss, and power failure. All alarms should be distinct and easy to identify. Also, if alarm volume is adjustable, it should not be

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possible to turn the volume down so low that the alarm is inaudible. The alarm silence feature must reactivate automatically within two minutes if the condition is not corrected. If an alarm is silenced, a visual display should clearly indicate which alarm is disabled. The delivered O2 or O2/air mixture should be monitored with an O2 analyzer that includes an alarm for concentrations outside acceptable ranges. The analyzer should be included with the ventilator. The controls (i.e., switches, knobs) should be visible and clearly identified, and their functions should be selfevident. The design should prevent misinterpretation of displays and control settings. Controls should be protected against accidental setting changes (e.g., due to someone brushing against the panel) and be sealed against fluid penetration. Patient and operator safety and system performance should not be adversely affected by fluid spills.

Other considerations

Current ventilator designs offer an often complicated variety of options, requiring a knowledgeable user. Staff shortages and frequent employee turnover in some hospitals often make adequate formal training in the use of clinical equipment difficult. Therefore, ventilators with good human-factors design offer a significant advantage. In addition, standardizing equipment helps minimize retraining and confusion, and suppliers often give significant discounts when multiple units are purchased. A wide range of modes, variables monitored and controlled, and alarms is offered among different ventilators. These features should be evaluated to determine which are needed for a particular patient population and clinical setting.

Cost containment

Because intensive care ventilators entail ongoing maintenance and operational costs, the initial acquisition cost does not accurately reflect the total cost of ownership. Therefore, a purchase decision should be based on issues such as life-cycle cost (LCC), local service support, discount rates and non-price-related benefits offered by the supplier, and standardization with existing equipment in the department or hospital (i.e., purchasing all ventilators from one supplier). An LCC analysis can be used to compare high-cost alternatives and/or to determine the positive or negative economic value of a single alternative. For example, hospitals can use LCC analysis techniques to examine the cost-effectiveness of leasing or renting equipment versus purchasing the equipment outright. Because it examines the cash-flow impact of initial acquisition costs and operating costs over a period of time, LCC analysis is most useful for comparing alternatives with different cash flows and for revealing the total costs of equipment ownership. One LCC technique--present value (PV) analysis--is especially useful because it accounts for inflation and for the time value of money (i.e., money received today is worth more than money received at a later date). Conducting a PV/LCC analysis often demonstrates that the cost of ownership includes more than just the initial acquisition cost and that a small increase in initial acquisition cost may produce significant savings in long-term operating costs. The PV is calculated using the annual cash outflow, the dollar discount factor (the cost of capital), and the lifetime of the equipment (in years) in a mathematical equation. The following represents a sample seven-year PV/LCC analysis for an intensive care ventilator.

Present Value/Life-Cycle Cost Analysis

Assumptions Operating costs are considered for years 1 through 7 Dollar discount factor is 6.5%

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Capital Costs Ventilator = $27,000 Total Capital Costs = $27,000 Operating Costs Disposables = $1,040/year ($20 disposable breathing circuits and accessories are changed once a week) Service contract, years 1 through 7 = $1,100/year Total Operating Costs = $2,140/year PV = ($41,185) Other costs not included in the above analysis that should be considered for budgetary planning include those associated with the following: Reusable breathing circuits Disinfection of reusable breathing circuits Parts replaced during preventive maintenance (e.g., sensors) Staff training Utilities Contributions to overhead Inflation rate is 4% for disposables, 6% for a full-service contract Disposable breathing circuits are changed once a week

Clearly, the expected expense of operating an intensive care ventilator is significantly greater than the initial cost of the device. Hospitals should evaluate how they plan to use the ventilator; in particular, the decision to use disposable or reusable breathing circuits will affect the cost of operation. 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. Purchasing a service contract 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. ECRI Institute recommends that, to maximize bargaining leverage, hospitals negotiate pricing for service contracts before the system is purchased. Additional service contract discounts may be negotiable for multipleyear agreements or for service contracts that are bundled with contracts on other similar equipment in the department or hospital. For customized analyses and purchase decision support, readers should contact ECRI Institute's SELECTplusTM Group.

Stage of development

The mid-1980s witnessed the introduction of microprocessor-based ventilators that could be easily upgraded to perform additional operations by a simple software change. However, the use of microprocessors has given the operator a vast and sometimes confusing number of options to choose from. In the near future, monitors for gas exchange and hemodynamics may be merged with the ventilator's existing data collection system. This combined system may alert the clinician to necessary control changes. Recently, the concept of tracheal triggering was introduced. Tracheal pressure triggering has substantially reduced the work of breathing in lung models simulating spontaneous breathing with CPAP. This reduction occurs because a small level of pressure support is produced at the proximal endotracheal tube. Tracheal triggering may also be beneficial when small endotracheal tubes are used.

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There has been a recent trend to collect and store information from medical devices electronically and to display information from one device on another. The Institute of Electrical and Electronics Engineers has been developing a standard communication protocol called the medical information bus, which allows many types of medical devices to communicate with each other and to transfer data in a standardized format. Institutions with more than one brand of ventilator may thereby be able to automate their respiratory care charting. In addition, most ventilators now offer a noninvasive delivery option. This option delivers ventilation usually through a mask that fits over the mouth and nose.

Bibliography

Branson R. Understanding and implementing advances in ventilator capabilities. Curr Opin Crit Care 2004 Feb;10(1):23-32. Branson RD, Campbell RS. Sighs: wasted breath or breath of fresh air? Respir Care 1992 May;37(5):462-8. Calzia E, Lindner KH, Stahl W, et al. Work of breathing, inspiratory flow response, and expiratory resistance during continuous positive airway pressure with the ventilators EVITA-2, EVITA-4, and SV 300. Intensive Care Med 1998 Sep;24(9):931-8. Chao DC, Scheinhorn DJ, Stearn-Hassenpflug M. Patient-ventilator trigger asynchrony in prolonged mechanical ventilation. Chest 1997 Dec;112(6):1592-9. Cook D, De Jonghe B, Brochard L, et al. Influence of airway management on ventilator-associated pneumonia: evidence from randomized trials. JAMA 1998 Mar 11;279(10):781-7. Del Valle RM, Hecker RB. A review of ventilatory modalities used in the intensive care unit. Am J Anesthesiol 1995 Jan-Feb;22(1):23-30. ECRI. Alarm-enhancement systems for ventilators [guidance article]. Health Devices 2004 Jan;33(1):5-23. Alarm-enhancement systems for ventilators: problems with physiologic monitoring interfaces. Health Devices 2004 Oct;33(10):354-5. Intensive care ventilators [evaluation]. Health Devices 1998 Sep-Oct;27(9-10):308-62. Intensive care ventilators [evaluation]. Health Devices 2002 Dec;31(12):441-54. Intensive care ventilators [evaluation]. Health Devices 2006 Apr;35(4):115-48. Intensive care ventilators [evaluation update]. Health Devices 2006 Jun;35(6):230. Intensive care ventilators [update evaluation]. Health Devices 2000 Jul-Aug;29(7-8):249-73. Minimum requirements for ventilatory testing [guidance article]. Health Devices 1998 Sep-Oct;27(9-10):363-4. Fenstermacher D, Hong D. Mechanical ventilation: what have we learned? Crit Care Nurs 2004 Jul-Sep;27(3):25894. Goulet R, Hess D, Kacmarek RM. Pressure vs flow triggering during pressure support ventilation. Chest 1997 Jun;111(6):1649-53. Hillberg RE, Johnson DC. Noninvasive ventilation. N Engl J Med 1997 Dec 11;337(24):1746-52. Holbrook PJ, Guiles SP. Response time of four pressure support ventilators: effect of triggering method and bias flow. Respir Care 1997 Oct;42(10):952-9. Joiner GA, Salisbury D, Bollin GE. Utilizing quality assurance as a tool for reducing the risk of nosocomial ventilator-associated pneumonia. Am J Med Qual 1996 Summer;11(2):100-3.

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MacIntyre NR, McConnell R, Cheng KC, et al. Patient-ventilator flow dyssynchrony: flow-limited versus pressure-limited breaths. Crit Care Med 1997 Oct;25(10):1671-7. Vitacca M. New things are not always better: proportional assist ventilation vs. pressure support ventilation. Intensive Care Med 2003 Jul;29(7):1038-40. Wilkins RL, Stoller JK. Egan's fundamentals of respiratory care. 8th ed. St. Louis: CV Mosby; 2003.

Supplier information

ACOMA

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

BIO-MED DEVICES

Bio-Med Devices Inc [104004] 61 Soundview Rd Guilford, CT 06437 Phone: (203) 458-0202, (800) 224-6633 Fax: (203) 458-0440 Internet: http://www.biomeddevices.com E-mail: [email protected]

CARDINAL HEALTH/PULMONETIC SYSTEMS LTV

Cardinal Health Pulmonetic Systems Div [453002] 17400 Medina Rd Suite 100 Minneapolis, MN 55447 Phone: (763) 398-8300, (866) 752-1438 Fax: (763) 398-8400 Internet: http://www.pulmonetic.com E-mail: [email protected]

CARDINAL HEALTH/VIASYS HEALTHCARE

Bear Medical Systems Inc Cardinal Health Critical Care Div [101095] 1100 Bird Center Dr Palm Springs, CA 92262 Phone: (760) 778-7200, (800) 937-3750 Fax: (760) 778-7295 Internet: http://www.viasyshealthcare.com Cardinal Health UK Ltd [439234] Frankland Road Blagrove Swindon SN5 8RU England Phone: 44 (870) 6011011 Fax: 44 (870) 6011937 Internet: http://www.cardinal.com E-mail: [email protected]

COVIDIEN PURITAN BENNETT

Covidien Nellcor/Puritan Bennett Div Covidien (US) [452303] 6135 Gunbarrel Ave Boulder, CO 82301-3214

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Phone: (305) 530-2300, (800) 635-5267 Internet: http://www.covidien.com Covidien Nellcor/Puritan Bennett/Melville (Canada) Div Covidien (US) [452300] 303 Terry Fox Dr Kanata ON K2K 3J1 Canada Phone: (613) 238-1840, (800) 663-3336 Fax: (613) 238-1291, (866) 821-7773 Internet: http://www.covidien.com Covidien (United Kingdom) Div Covidien (US) [452449] 154 Fareham Road Gosport PO13 OAS England Phone: 44 (1329) 224000 Fax: 44 (1329) 220213 Internet: http://www.covidien.com E-mail: [email protected] Covidien (Japan) Div Covidien (US) [452444] 10-2 Yoga 4-chome Setagaya-ku Tokyo 158-8615 Japan Phone: 81 (3) 57171700 Fax: 81 (3) 57171317 Internet: http://www.covidien.com E-mail: [email protected]

DRAEGER

Draeger Medical UK Ltd [157747] The Willows Mark Road Hemel Hempstead HP2 7BW England Phone: 44 (1442) 213542 Fax: 44 (1442) 240327 Internet: http://www.draeger.com Draeger Medical Inc [371341] 3135 Quarry Rd Telford, PA 18969 Phone: (215) 721-5400, (800) 437-2437 Fax: (215) 723-5935 Internet: http://www.draegermedical.com E-mail: [email protected] Draeger Southeast Asia Pte Ltd Medical Div [354511] 73 Science Park Drive #02-01/04 Cintech 1 Singapore Republic of Singapore Phone: 65 8729278 Fax: 65 7792165 Internet: http://www.draegermedical.com E-mail: [email protected] Draegerwerk AG [139322] Moislinger Allee 53-55 Postfach 1339 Luebeck D-23558 Germany

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Phone: 49 (451) 8820 Fax: 49 (451) 8821654 Internet: http://www.draeger.com

eVENT MEDICAL

eVent Medical Ltd [403318] 6A Liosban Business Park Galway Ireland Phone: 353 (91) 764472 Fax: 353 (91) 764379 Internet: http://www.event-medical.com E-mail: [email protected] eVent Medical Ltd (US) [403413] 81 Columbia Suite 101 Aliso Viejo, CA 92656 Phone: (949) 360-8368 Fax: (949) 360-1924 Internet: http://www.event-medical.com E-mail: [email protected]

GE HEALTHCARE (DATEX-OHMEDA)

GE Healthcare Clinical Systems Devices (Netherlands) [452809] Postbus 22 Hoevelaken NL-3870 CA The Netherlands Phone: 31 (33) 2541222 Fax: 31 (33) 2541223 Internet: http://www.gehealthcare.com Datex-Ohmeda Inc Div GE Healthcare [351254] 3030 Ohmeda Dr PO Box 7550 Madison, WI 53707-7550 Phone: (608) 221-1551, (800) 345-2700 Fax: (608) 222-9147 Internet: http://www.gehealthcare.com GE Healthcare Asia (Japan) [300443] 4-7-127 Asahigaoka Hino-shi Tokyo 191-8503 Japan Phone: 81 (3) 425826820 Fax: 81 (3) 425826830 Internet: http://www.gehealthcare.com.jp E-mail: [email protected]

HAMILTON MEDICAL

Hamilton Medical AG [138228] via Nova Rhaezuens CH-7403 Switzerland Phone: 41 (81) 6606010 Fax: 41 (81) 6606020 Internet: http://www.hamilton-medical.ch E-mail: [email protected] Hamilton Medical Asia Pacific [418184] Temasek Avenue 1 #27-01 Millenia Tower Singapore 039192 Republic of Singapore

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Phone: 65 63569541 Fax: 65 63531673 Internet: http://www.hamilton-medical.com Hamilton Medical Inc [105689] 4990 Energy Way PO Box 30008 Reno, NV 89520-3008 Phone: (775) 858-3200, (800) 426-6331 Fax: (775) 856-5621 Internet: http://www.hamilton-medical.com E-mail: [email protected]

IMPACT

Impact Instrumentation Inc [101885] 27 Fairfield Pl PO Box 508 West Caldwell, NJ 07006-0508 Phone: (973) 882-1212, (800) 969-0750 Fax: (973) 882-4993 Internet: http://www.impactii.com E-mail: [email protected]

INTERMED

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

MAQUET

Maquet Critical Care AB A Getinge Group Co [439169] Rontgenvagen 2 Solna S-171 95 Sweden Phone: 46 (8) 7307300 Fax: 46 (8) 985775 Internet: http://www.maquet.com/criticalcare E-mail: [email protected] Maquet GmbH & Co KG A Getinge Group Co [305482] Kehlerstrasse 31 Rastatt D-76437 Germany Phone: 49 (7222) 9320 Fax: 49 (7222) 932828 Internet: http://www.maquet.com E-mail: [email protected] Maquet Inc A Getinge Group Co [336117] 1140 Rt 22 E Suite 202 Bridgewater, NJ 08807 Phone: (908) 947-2300, (888) 627-8383 Fax: (908) 947-2301 Internet: http://www.maquet.com/us E-mail: [email protected]

NEWPORT

Newport Medical Instruments Europe [187402] 18 Pasture Road

©2008 ECRI Institute. All Rights Reserved

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Barton-upon-Humber DN18 5HN England Phone: 44 (4682) 31311 Internet: http://www.ventilators.com E-mail: [email protected] Newport Medical Instruments Inc [105093] PO Box 2600 Newport Beach, CA 92658 Phone: (714) 427-5811, (800) 451-3111 Fax: (714) 427-0489 Internet: http://www.ventilators.com E-mail: [email protected]

RESPIRONICS

Fuji Respironics Co Ltd Sub Philips Medical Systems [347587] 1-5-32 Yushima Bonkyo-ku Tokyo 113-0034 Japan Phone: 81 (3) 52809611 Fax: 81 (3) 52800102 Internet: http://www.respironics.com E-mail: [email protected] Respironics France Sub Philips Medical Systems [321323] 2 rue de Chateau de Bel Air boite postale 30505 Carquefou Cedex BP-30505 France Phone: 33 (1) 47523030 Fax: 33 (1) 55601989 Internet: http://www.respironics.com E-mail: [email protected] Respironics Inc Sub Philips Medical Systems [101639] 1010 Murry Ridge Ln Murrysville, PA 15668-8525 Phone: (724) 387-5200, (800) 345-6443 Fax: (724) 387-5010 Internet: http://www.respironics.com

SAIME/RESMED

Saime SA [263810] 25 rue de l'Etain Savigny-le-Temple F-77176 France Phone: 33 (1) 64191111 Fax: 33 (1) 64418130 Internet: http://www.saime.fr E-mail: [email protected] ResMed (UK) Ltd [345621] 67B Milton Park Abingdon OX14 4RX England Phone: 44 (1235) 862997 Fax: 44 (1235) 831336 Internet: http://www.resmed.com E-mail: [email protected]

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ResMed Corp [177147] 14040 Danielson St Poway, CA 92064-6857 Phone: (858) 746-2400, (800) 424-0737 Fax: (858) 746-2900 Internet: http://www.resmed.com E-mail: [email protected]

SIARE

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

TAEMA

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

VERSAMED/GE HEALTHCARE

VersaMed Inc (Indian Sub-Continent Office) A GE Healthcare Co [449826] D-25 GF Pamposh Enclave GK-1 New Delhi 110 148 India Phone: 91 (11) 26287418 Fax: 91 (11) 26448836 Internet: http://www.versamed.com E-mail: [email protected] VersaMed Medical Systems Inc A GE Healthcare Co [378254] 2 Blue Hill Plaza Pearl River, NY 10965 Phone: (845) 770-2840, (800) 475-9239 Fax: (845) 770-2850 Internet: http://www.versamed.com E-mail: [email protected] VersaMed Medical Systems Inc (Singapore) A GE Healthcare Co [449824] Block 518 #08-214 Serangoon North Avenue 4 Singapore 550518 Republic of Singapore Phone: 65 62873489 Fax: 65 62872489 Internet: http://www.versamed.com E-mail: [email protected]

Note: The data in the charts derive from suppliers' specifications and have not been verified through independent testing by ECRI Institute or any other agency. Because test methods vary, different products' specifications are not always comparable. Moreover, products and specifications are subject to frequent changes. ECRI Institute is not responsible for the quality or validity of the information presented or for any adverse consequences of acting on such information.

©2008 ECRI Institute. All Rights Reserved

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Ventilators, Intensive Care

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) 825-6000, ext. 5265; +1 (610) 834-1275 (fax); or [email protected] (e-mail). Last updated October 2008

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Policy Statement

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

About ECRI Institute

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

©2008 ECRI Institute. All Rights Reserved

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Ventilators, Intensive Care Product Comparison Chart

MODEL ECRI INSTITUTE'S RECOMMENDED SPECIFICATIONS1 Basic IC Ventilators ECRI INSTITUTE'S RECOMMENDED SPECIFICATIONS1 Mid/High IC Ventilators ACOMA ART-21EX Not specified Not specified Not specified Not specified 50-2,000 5-80 1-40 plus PEEP 0-60 0.3-5 (PCV, SIMV) Not specified 1:0.3 to 1:3 0-30% inspiratory time Not specified 21-100 Yes 0-20 1-40 plus PEEP Yes Flow 5 NA Yes Yes None specified BIO-MED DEVICES Crossvent CV-3+ Worldwide Yes Yes Adult, pediatric 5-2,500 1-120 0-120 5-150 0.1-3 0.2-99.9 3:1 to 1:99 No No 21-100 with optional blender Yes 0-35 0-50 No Pressure NA No Yes Not specified None specified

WHERE MARKETED FDA CLEARANCE CE MARK (MDD) PATIENT TYPE CONTROLS Tidal volume, mL Inspiratory flow, L/min Inspiratory pressure, cm H2O Respiratory rate, bpm Inspiratory time, sec Expiratory time, sec IE ratio Inspiratory hold/plateau Expiratory hold FiO2, % Manual breath PEEP/CPAP, cm H2O Pressure support, cm H2O Nebulizer Trigger mechanism Bias/base flow range, L/min Pressure slope/ramp adjustment Sigh 100% O2 Others

50-800 3-180 0-80 6-120 0-3 pause 1-8 1:4 to 4:1 0-3 sec 0-3 sec 30-90 Yes 0-45 0-45 Optional Pressure, flow, both 1-20 Yes/yes Optional

50-800 3-180 5-60 6-120 0-3 pause 1-8 1:4 to 4:1 0-3 sec 0-3 sec 30-90 Yes 0-45 0-45 Optional Pressure, flow, both 1-20 Yes/yes Optional

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

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Ventilators, Intensive Care Product Comparison Chart

MODEL ECRI INSTITUTE'S RECOMMENDED SPECIFICATIONS1 Basic IC Ventilators ECRI INSTITUTE'S RECOMMENDED SPECIFICATIONS1 Mid/High IC Ventilators ACOMA ART-21EX BIO-MED DEVICES Crossvent CV-3+

OPERATING MODES Assist/control Volume breaths Pressure breaths SIMV Volume breaths SIMV Pressure breaths Pressure support Spontaneous/CPAP Pressure support Apnea-backup vent Combination modes Active/responsive valve Bilevel/APRV Others MONITORED PARAMETERS Pressure PIP MAP PEEP Volume Tidal Minute Spontaneous minute FiO2 Respiratory rate Inspiratory time Expiratory time IE Others

Yes Yes Yes Optional Yes Yes Yes

Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes User preference

Yes Yes Yes Yes Yes Yes Yes Not specified Not specified Not specified None specified

Yes Yes Yes Yes Yes Yes Yes Not specified Not specified Not specified None specified

User preference

Yes Yes Yes Yes Yes Optional Yes Yes Yes Yes Yes Based on user requirements

Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Based on user requirements

Yes Yes Yes Yes Yes Yes Optional Yes Yes No Yes None specified

Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes None specified

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

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Ventilators, Intensive Care Product Comparison Chart

MODEL ECRI INSTITUTE'S RECOMMENDED SPECIFICATIONS1 Basic IC Ventilators Yes Yes Yes Yes Optional Yes Yes Yes Yes Optional Optional ECRI INSTITUTE'S RECOMMENDED SPECIFICATIONS1 Mid/High IC Ventilators Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes ACOMA ART-21EX Yes Yes Yes Yes Yes Yes Not specified Not specified Yes Yes Yes Not specified None specified Yes Yes Yes Yes Valve leak, sensor failure By user requirements Optional Optional Optional Required Required Preferred Preferred Yes Yes Yes Yes Valve leak, sensor failure By user requirements Optional Optional Optional Required Required Preferred Preferred Yes Yes Yes Yes CPU error Flow rate, preset failure No No No Not specified Not specified Not specified Not specified BIO-MED DEVICES Crossvent CV-3+ Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes None specified Yes Yes Yes Yes Yes None specified RS232 Not specified Not specified Not specified Not specified Not specified Not specified

PATIENT ALARMS FiO2 Low minute volume Low inspiratory pressure High pressure Loss of PEEP Apnea High continuous pressure/occlusion Inverse IE High respiratory rate High minute volume High PEEP Breathing circuit disconnect Others EQUIPMENT ALARMS Gas supply failure Power failure Vent inoperative Low battery Self-diagnostics Others INTERFACING Output ports Remote alarm/display Analog output Report generation Display Hard copy Archival disk Network

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

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Ventilators, Intensive Care Product Comparison Chart

MODEL ECRI INSTITUTE'S RECOMMENDED SPECIFICATIONS1 Basic IC Ventilators User preference User customizable Not specified Not specified Optional O2, air 35-65 psi Standard Required Any common type 1 ECRI INSTITUTE'S RECOMMENDED SPECIFICATIONS1 Mid/High IC Ventilators User preference User customizable Not specified Not specified Optional O2, air 35-65 psi Standard Required Any common type 1 ACOMA ART-21EX LED Not specified Not specified Not specified Not specified Optional O2, air 20 kPa Not specified 100-240, 50/60 Hz Not specified 330 Yes Not specified Not specified Not specified Not specified Not specified Not specified Not specified Not specified Not specified 125 x 40 x 62 (50 x 15.7 x 24.8) 67 (148) BIO-MED DEVICES Crossvent CV-3+ Color LCD with backlit touchscreen Not specified No Yes Not specified Not specified O2, air 214-517 kPA (31-75 PSI) Not specified 110/220 Not specified Not specified Yes Ni-MH 6 Yes 5 Not specified Not specified Not specified Not specified Not specified 28 x 25.4 x 14 (11 x 10 x 5.5) 4.8 (10.5)

DISPLAY TYPES DATA DISPLAYED MRI COMPATIBILITY SUITABLE FOR AIRCRAFT USE Approved by PNEUMATIC POWER Compressor Compressed gases Pressure ranges Turbine/piston LINE POWER, VAC Current, amps Watts INTERNAL BATTERY Type (number) Operating time, hr Rechargeable Recharging time, hr EXTERNAL BATTERY Type (number) Operating time, hr Rechargeable Recharging time, hr H x W x D, cm (in) WEIGHT, kg (lb)

This is the fourth of five pages covering the above model(s). These specifications continue onto the next page.

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Ventilators, Intensive Care Product Comparison Chart

MODEL ECRI INSTITUTE'S RECOMMENDED SPECIFICATIONS1 Basic IC Ventilators ECRI INSTITUTE'S RECOMMENDED SPECIFICATIONS1 Mid/High IC Ventilators ACOMA ART-21EX BIO-MED DEVICES Crossvent CV-3+

PURCHASE INFORMATION List price Warranty Service Factory/on-site Training 3rd-party service Parts availability Delivery time, ARO Year first sold Number sold USA/worldwide Fiscal year OTHER SPECIFICATIONS

Not specified 1 year Not specified Not specified Not specified Not specified Not specified Not specified Not specified Not specified None specified.

Not specified 1 year Yes/yes Yes Not specified Yes Not specified 2005 Not specified January to December Foreign language menus; 12-30 V input jack for transport; optional air entrainment for 50% O2 concentration. 17429 October 2008

UMDNS CODE(S) LAST UPDATED Supplier Footnotes

17429

1These

17429

1These

17429 October 2008

recommendations are the opinions of ECRI Institute technology experts. ECRI Institute assumes no liability for decisions made based on this data.

recommendations are the opinions of ECRI Institute technology experts. ECRI Institute assumes no liability for decisions made based on this data.

Model Footnotes Data Footnotes

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Ventilators, Intensive Care Product Comparison Chart

MODEL BIO-MED DEVICES Crossvent CV-4+ Worldwide Yes Yes Adult, pediatric, neonatal 5-2,500 1-120 0-120 5-150 0.1-3 0.2-99.9 3:1 to 1:99 No No 21-100 with optional blender Yes 0-35 0-50 No Pressure NA No Yes Not specified None specified CARDINAL HEALTH/PULMONETIC SYSTEMS LTV LTV 1000 Worldwide Yes Yes Adult, pediatric 50-2,000 10-100 volume-controlled breaths, up to 160 PC/PS/spontaneous breaths 1-99 pressure control; off, 160 pressure support 0-80 0.3-9.9 346 msec minimum 1:4 to 4:1 6 sec maximum 6 sec maximum 21-100 1 x current settings 0-20 Off, 1-60 May be placed in the circuit Flow 10 Yes/yes No Yes Pressure control, sensitivity CARDINAL HEALTH/PULMONETIC SYSTEMS LTV LTV 1200 Worldwide Yes Yes Adult, pediatric 50-2,000 10-100 volume-controlled breaths, up to 160 PC/PS/spontaneous breaths 1-99 pressure control; off, 160 pressure support 0-80 0.3-9.9 346 msec minimum 1:4 to 4:1 6 sec maximum 6 sec maximum 21-100 1 x current settings 0-20 Off, 1-60 May be placed in the circuit Flow 0 or 10 Yes/yes No Yes Pressure control, sensitivity CARDINAL HEALTH/VIASYS HEALTHCARE AVEA Worldwide Yes Yes Adult, pediatric, neonatal 2-2,500 0.4-150, 180 spontaneous maximum 0-90 1-150 0.15-5 Depends on rate 4:1 maximum inverse 0-3 sec 3/20 sec 21-100 Yes 0-50 0-90 20 min Pressure, flow 0.4-5 0-9 relative scale Yes Yes, adjustable % increase Advanced settings include flow cycle %, PSV flow %, PSVT maximum, volume limit, Vsync, AAC, machine volume, Thigh sync, Tlow sync, Thigh psv, waveform

WHERE MARKETED FDA CLEARANCE CE MARK (MDD) PATIENT TYPE CONTROLS Tidal volume, mL Inspiratory flow, L/min Inspiratory pressure, cm H2O Respiratory rate, bpm Inspiratory time, sec Expiratory time, sec IE ratio Inspiratory hold/plateau Expiratory hold FiO2, % Manual breath PEEP/CPAP, cm H2O Pressure support, cm H2O Nebulizer Trigger mechanism Bias/base flow range, L/min Pressure slope/ramp adjustment Sigh 100% O2 Others

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

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Ventilators, Intensive Care Product Comparison Chart

MODEL BIO-MED DEVICES Crossvent CV-4+ OPERATING MODES Assist/control Volume breaths Pressure breaths SIMV Volume breaths SIMV Pressure breaths Pressure support Spontaneous/CPAP Pressure support Apnea-backup vent Combination modes Active/responsive valve Bilevel/APRV Others CARDINAL HEALTH/PULMONETIC SYSTEMS LTV LTV 1000 CARDINAL HEALTH/PULMONETIC SYSTEMS LTV LTV 1200 CARDINAL HEALTH/VIASYS HEALTHCARE AVEA

Yes Yes Yes Yes Yes Yes Yes Not specified Not specified Not specified None specified

Yes Yes Yes Yes Yes Yes Yes Not specified Not specified Not specified NPPV

Yes Yes Yes Yes Yes Yes Yes Not specified Not specified Not specified NPPV

Yes Yes Yes Yes Yes Yes Yes PRVC, machine volume Yes Yes APRV/biphasic, TCPL, PRVC, Vsync, heliox, noninvasive infant nasal CPAP

MONITORED PARAMETERS Pressure PIP MAP PEEP Volume Tidal Minute Spontaneous minute FiO2 Respiratory rate Inspiratory time Expiratory time IE Others

Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes None specified

Yes Yes Yes Yes Yes Yes Set Yes No No Yes Static compliance, autoPEEP, calculated peak flow, patient effort

Yes Yes Yes Yes Yes Yes Set Yes No No Yes Static compliance, autoPEEP, calculated peak flow, patient effort, SBT f/Vt, SBT f

Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes MIP/P100, P-Flex maneuver, autoPEEP, Bicore esophageal parameters, mL/kg, Cstat, Cdyn, ENTCO2, VtCO2, VCO2, Vd/Vt, Vd airway, VD physiologic, VA, Ol, P/F, capnogram, all parameters trended for 24 hr, Vti/kg; Vte/kg; spontaneous Vti, Vte, Vti/kg, and Vte/kg; mand Vt; mand Vt/kg; Vdel; % leak; Ve; Ve/kg; spontaneous Ve and Ve/kg; spontaneous rate; inspiratory and expiratory time; I:E ratio; rapid shallow breathing index; MAP; plateau pressure; PEEP; air inlet pressure; O2 inlet pressure; Cdyn; Cdyn/kg; Cstat; Cstat/kg; respiratory system resistance; events This is the second of five pages covering the above model(s). These specifications continue onto the next three pages.

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Ventilators, Intensive Care Product Comparison Chart

MODEL BIO-MED DEVICES Crossvent CV-4+ PATIENT ALARMS FiO2 Low minute volume Low inspiratory pressure High pressure Loss of PEEP Apnea High continuous pressure/occlusion Inverse IE High respiratory rate High minute volume High PEEP Breathing circuit disconnect Others EQUIPMENT ALARMS Gas supply failure Power failure Vent inoperative Low battery Self-diagnostics Others Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes None specified CARDINAL HEALTH/PULMONETIC SYSTEMS LTV LTV 1000 Yes Yes Yes Yes Not specified Yes Not specified Not specified Yes Not specified Yes Yes None specified CARDINAL HEALTH/PULMONETIC SYSTEMS LTV LTV 1200 Yes Yes Yes Yes Yes Yes Not specified Not specified Yes Not specified Yes Yes Low PEEP, SBT high f/Vt, SBT low f/Vt, SBT high f, SBT low f Yes Yes Yes Yes Yes High and low O2 inlet pressure, external power low RS232, RJ11-4 Yes No With LTM graphics monitor With LTM graphics monitor With LTM graphics monitor With LTM graphics monitor CARDINAL HEALTH/VIASYS HEALTHCARE AVEA Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes No Yes Low Vt, high Vt, high breath rate, high ETCO2, low ETCO2, invalid GasID Yes Yes Yes Yes Yes Fan failure, safety valve open, invalid gas ID, ILV disconnect, heliox loss CO2 sensor RS232, SVGA, parallel Yes Yes Full-color SVGA LCD Printer output Internal storage RS232, VOXP and GSP communication protocols

Yes Yes Yes Yes Yes None specified

Yes Yes Yes Yes Yes High and low O2 inlet pressure, external power low RS232, RJ11-4 Yes No With LTM graphics monitor With LTM graphics monitor With LTM graphics monitor With LTM graphics monitor

INTERFACING Output ports Remote alarm/display Analog output Report generation Display Hard copy Archival disk Network

RS232 Not specified Not specified Not specified Not specified Not specified Not specified

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

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Ventilators, Intensive Care Product Comparison Chart

MODEL BIO-MED DEVICES Crossvent CV-4+ Color LCD with backlit touchscreen Not specified CARDINAL HEALTH/PULMONETIC SYSTEMS LTV LTV 1000 LED, optional LCD Numbers CARDINAL HEALTH/PULMONETIC SYSTEMS LTV LTV 1200 LED, optional LCD Numbers CARDINAL HEALTH/VIASYS HEALTHCARE AVEA Graphics SVGA color LCD Waveform and loops on monitor with trends, userconfigurable monitored values Not specified Not specified Not specified

DISPLAY TYPES DATA DISPLAYED

MRI COMPATIBILITY SUITABLE FOR AIRCRAFT USE Approved by

No Yes Not specified

Not specified Yes Air Force (C-17, C-21A, C130EH, C-130J, KC-10, KC135 & WC-130J), Army (H60 MEDEVAC H-60 helicopter) Internal turbine NA to power vent 40-80 psi Turbine 90-240 3-5.5 36-66 Yes Sealed lead-acid (1) 1 Yes 8 Yes Lithium ion (1), sealed leadacid (2) 3-9 Yes Not specified 8 x 25 x 30 (3.2 x 9.8 x 11.8) 6.5 (14.5)

Pending Yes Army (H-60 MEDEVAC H60 helicopter)

PNEUMATIC POWER Compressor Compressed gases Pressure ranges Turbine/piston LINE POWER, VAC Current, amps Watts INTERNAL BATTERY Type (number) Operating time, hr Rechargeable Recharging time, hr EXTERNAL BATTERY Type (number) Operating time, hr Rechargeable Recharging time, hr H x W x D, cm (in) WEIGHT, kg (lb)

Not specified O2, air 214-517 kPA (31-75 PSI) Not specified 110/220 Not specified Not specified Yes Ni-MH (not specified) 6 Yes 5 Not specified Not specified Not specified Not specified Not specified 28 x 25.4 x 14 (11 x 10 x 5.5) 4.8 (10.5)

Internal turbine NA to power vent 40-80 psi Turbine 90-240 3-5.5 36-66 Yes Sealed lead-acid (1) 1 Yes 8 Yes Lithium ion (1), sealed leadacid (2) 3-9 Yes Not specified 8 x 25 x 30 (3.2 x 9.8 x 11.8) 6.5 (14.5)

Battery-backed scroll pump O2, air, heliox 20-80 psi Scroll pump 100/120/230/240 3 (120 VAC) 360 Yes Ni-MH (1) 1 on wall air or 0.5 on compressor Yes 4 Yes Sealed lead-acid (2) 4 on wall air or 2 on compressor, including internal Yes 12 43.2 x 40.6 x 26.7 (17 x 16 x 10.5) 36.3 (80) with compressor

This is the fourth of five pages covering the above model(s). These specifications continue onto the next page.

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Ventilators, Intensive Care Product Comparison Chart

MODEL BIO-MED DEVICES Crossvent CV-4+ PURCHASE INFORMATION List price Warranty Service Factory/on-site Training 3rd-party service Parts availability Delivery time, ARO Year first sold Number sold USA/worldwide Fiscal year OTHER SPECIFICATIONS CARDINAL HEALTH/PULMONETIC SYSTEMS LTV LTV 1000 CARDINAL HEALTH/PULMONETIC SYSTEMS LTV LTV 1200 CARDINAL HEALTH/VIASYS HEALTHCARE AVEA

Not specified 1 year Yes/yes Yes Not specified Yes Not specified 2007 Not specified January to December Foreign language menus; 12-30 V input jack for transport; optional air entrainment for 50% O2 concentration.

Not specified 1 year Yes/yes Yes Yes Yes ~3-5 days 1998 Not specified Not specified O2 flush, O2 cylinder duration, variable rise time; variable termination criteria for pressure-support and pressure-control breaths. Meets requirements of cETL, IEC 60601-2-12, and ISO 13485.

Not specified 1 year Yes/yes Yes Yes Yes ~3-5 days 2006 Not specified Not specified Patient presets, spontaneous breathing trial (SBT), O2 flush, O2 cylinder duration, variable rise time; variable termination criteria for pressure-support and pressure-control breaths. Meets requirements of cETL, IEC 60601-1, and ISO 13485.

$22,995-32,995, depends on options 2 years Yes/yes Class at factory In some areas Yes 30-45 days 2002 Not specified/>8,000 July to June Tank holder; esophageal balloon/tracheal catheter monitoring for adult/pediatrics on comprehensive units; proximal hotwire flow sensing on deluxe units; proximal variable orifice flow sensing on comprehensive units; onboard barometric pressure sensor; optional compressor and heliox on standard model; optional external battery on deluxe stand; optional volumetric capnography. 17429 October 2008

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

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Ventilators, Intensive Care Product Comparison Chart

MODEL CARDINAL HEALTH/VIASYS HEALTHCARE Vela Worldwide Yes Yes Adult, pediatric 50-2,000 10-140/180 spontaneous maximum 1-100 2-80 0.3-10 Depends on rate 4:1 maximum inverse 6 sec maximum; off, 0.1-2 sec 6 sec maximum 21-100 Yes 0-35 Off, 1-60 Off, 1 to 60 min Flow with pressure backup 10-20 No/no Yes Yes Advanced settings include PC flow cycle, PSV flow cycle, PSVT maximum, waveform CARDINAL HEALTH/VIASYS HEALTHCARE Vela + Worldwide Yes Yes Adult, pediatric 50-2,000 10-140/180 spontaneous maximum 1-100 2-80 0.3-10 Depends on rate 4:1 maximum inverse 6 sec maximum; off, 0.1-2 sec 6 sec maximum 21-100 Yes 0-35 Off, 1-60 Off, 1 to 60 min Flow with pressure backup 10-20 No/no Yes Yes Advanced settings include volume limit, PC flow cycle, PSVT maximum, waveform CARDINAL HEALTH/VIASYS HEALTHCARE Vela Comprehensive Worldwide Yes Yes Adult, pediatric 50-2,000 10-140/180 spontaneous maximum 1-100 2-80 0.3-10 Depends on rate 4:1 maximum inverse 6 sec maximum; off, 0.1-2 sec 6 sec maximum 21-100 Yes 0-35 Off, 1-60 Off, 1 to 60 min Flow with pressure backup 10-20 No/no Yes Yes Advanced settings include volume limit, assured volume, PC flow cycle, PSV flow cycle, PSVT maximum, Vsync, AAC, Machine Volume, Thigh sync, Tlow sync, Thigh psv, waveform COVIDIEN PURITAN BENNETT 740 Worldwide Yes Yes Adult, pediatric 40-2,000 3-150 No PCV 1-70 No PCV >0.2 1:99 to 4:1 0-2 sec Not specified 21-100 Yes 0-35 0-70 Yes Flow NA No/no No 21-100 None specified

WHERE MARKETED FDA CLEARANCE CE MARK (MDD) PATIENT TYPE CONTROLS Tidal volume, mL Inspiratory flow, L/min Inspiratory pressure, cm H2O Respiratory rate, bpm Inspiratory time, sec Expiratory time, sec IE ratio Inspiratory hold/plateau Expiratory hold FiO2, % Manual breath PEEP/CPAP, cm H2O Pressure support, cm H2O Nebulizer Trigger mechanism Bias/base flow range, L/min Pressure slope/ramp adjustment Sigh 100% O2 Others

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

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Ventilators, Intensive Care Product Comparison Chart

MODEL CARDINAL HEALTH/VIASYS HEALTHCARE Vela CARDINAL HEALTH/VIASYS HEALTHCARE Vela + CARDINAL HEALTH/VIASYS HEALTHCARE Vela Comprehensive COVIDIEN PURITAN BENNETT 740

OPERATING MODES Assist/control Volume breaths Pressure breaths SIMV Volume breaths SIMV Pressure breaths Pressure support Spontaneous/CPAP Pressure support Apnea-backup vent Combination modes Active/responsive valve Bilevel/APRV Others

Yes Yes Yes Yes Yes Yes Yes No Not specified No None specified

Yes Yes Yes Yes Yes Yes Yes PRVC Not specified No Noninvasive A/C, SIMV, and CPAP/PSV; PRVC modes, Vsync

Yes Yes Yes Yes Yes Yes Yes PRVC, assured volume Not specified Yes APRV biphasic with PSV and time sync with volume limit, loops/trends, MIP/NIF, Vsync

Yes No Yes No Yes (0-70) Yes (0-70) Yes Not specified Not specified Not specified Speaking valve mode

MONITORED PARAMETERS Pressure PIP MAP PEEP Volume Tidal Minute Spontaneous minute FiO2 Respiratory rate Inspiratory time Expiratory time IE Others

Yes Yes Yes Yes Yes (VTi, VTe) Yes Yes Yes Yes Yes Yes Cstat, AutoPEEP, Palv

Yes Yes Yes Yes Yes (VTi, VTe) Yes Yes Yes Yes Yes Yes Cstat, AutoPEEP, Palv

Yes Yes Yes Yes Yes (VTi, VTe) Yes Yes Yes Yes Yes Yes All parameters trended for 24 hr, flow/volume, pressure/volume, loops, spontaneous rate, spontaneous Ve, MIP/NIF, Cstat, AutoPEEP, Palv

Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes None specified

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

©2008 ECRI Institute. All Rights Reserved

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Ventilators, Intensive Care Product Comparison Chart

MODEL CARDINAL HEALTH/VIASYS HEALTHCARE Vela Yes Yes Yes Yes Low pressure Yes Circuit fault 3 sec, time alert Yes No No Circuit fault High breath rate Yes Yes Yes 40% and 20% warnings Yes Test for lamp, leak, switch, alarm, and filter; touchscreen calibration RS232, SVGA, parallel Yes Direct video Full-color SVGA LCD HP 940 driver output Not specified VOXP and GSP communication protocols (Diamond models), BMI optional (VELA II models) CARDINAL HEALTH/VIASYS HEALTHCARE Vela + Yes Yes Yes Yes Low pressure Yes Circuit fault 3 sec, time alert Yes No No Circuit fault High breath rate Yes Yes Yes 40% and 20% warnings Yes Test for lamp, leak, switch, alarm, and filter; touchscreen calibration RS232, SVGA, parallel Yes Direct video Full-color SVGA LCD HP 940 driver output Not specified VOXP and GSP communication protocols (Diamond models), BMI optional (VELA II models) CARDINAL HEALTH/VIASYS HEALTHCARE Vela Comprehensive Yes Yes Yes Yes Low pressure Yes Circuit fault 3 sec, time alert Yes No No Circuit fault High breath rate Yes Yes Yes 40% and 20% warnings Yes Test for lamp, leak, switch, alarm, and filter; touchscreen calibration, CO2 sensor RS232, SVGA, parallel Yes Direct video Full-color SVGA LCD HP 940 driver output Not specified VOXP and GSP communication protocols (Diamond models), BMI optional (VELA II models) COVIDIEN PURITAN BENNETT 740 Yes, ±10% of setting 0-50 L 3-60 cm H2O 10-90 cm H2O Not specified 10-60 sec Defaults to HP limit Not specified Yes Not specified Not specified Yes None specified Yes Yes Yes Yes Electronics and pneumatics Disconnect, occlusion

PATIENT ALARMS FiO2 Low minute volume Low inspiratory pressure High pressure Loss of PEEP Apnea High continuous pressure/occlusion Inverse IE High respiratory rate High minute volume High PEEP Breathing circuit disconnect Others EQUIPMENT ALARMS Gas supply failure Power failure Vent inoperative Low battery Self-diagnostics Others

INTERFACING Output ports Remote alarm/display Analog output Report generation Display Hard copy Archival disk Network

RS232 (2), nurse call Yes No Optional Yes Yes Yes

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

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Ventilators, Intensive Care Product Comparison Chart

MODEL CARDINAL HEALTH/VIASYS HEALTHCARE Vela Graphics SVGA color LCD Waveforms, userconfigurable monitored values No Not specified Not specified Battery-backed turbine O2 40-80 psi Turbine 90-240, 47-65 Hz 2 36-220 Yes Ni-MH (not specified) 6 Yes 8 None NA NA NA NA 30.5 x 33 x 36.8 (12 x 13 x 14.5) 17.2 (38) CARDINAL HEALTH/VIASYS HEALTHCARE Vela + Graphics SVGA color LCD Waveforms, userconfigurable monitored values No Not specified Not specified Battery-backed turbine O2 40-80 psi Turbine 90-240, 47-65 Hz 2 36-220 Yes Ni-MH (not specified) 6 Yes 8 None NA NA NA NA 30.5 x 33 x 36.8 (12 x 13 x 14.5) 17.2 (38) CARDINAL HEALTH/VIASYS HEALTHCARE Vela Comprehensive Graphics SVGA color LCD Waveforms and loops on monitor with trends, userconfigurable monitored values No Not specified Not specified Battery-backed turbine O2 40-80 psi Turbine 90-240, 47-65 Hz 2 36-220 Yes Ni-MH (not specified) 6 Yes 8 None NA NA NA NA 30.5 x 33 x 36.8 (12 x 13 x 14.5) 17.2 (38) COVIDIEN PURITAN BENNETT 740 LCD Numbers, optional graphics

DISPLAY TYPES DATA DISPLAYED

MRI COMPATIBILITY SUITABLE FOR AIRCRAFT USE Approved by PNEUMATIC POWER Compressor Compressed gases Pressure ranges Turbine/piston LINE POWER, VAC Current, amps Watts INTERNAL BATTERY Type (number) Operating time, hr Rechargeable Recharging time, hr EXTERNAL BATTERY Type (number) Operating time, hr Rechargeable Recharging time, hr H x W x D, cm (in)

Not specified Not specified Not specified NA O2 40-90 psi Piston 100-240 2.9 (115 VAC) 290 Yes 24 VDC, 7 A-h (not specified) 2.5 under normal conditions Yes 2.5-3 Yes 24 VDC, 17 A-h (not specified) 7 under normal conditions Yes 7.5-8 37.8 x 51.5 x 37 (14.9 x 20.3 x 14.6), 125.5 x 51.5 x 37 (49.4 x 20.3 x 14.6) with cart 30 (66.2) ventilator, 18 (39.7) cart

WEIGHT, kg (lb)

This is the fourth of five pages covering the above model(s). These specifications continue onto the next page.

©2008 ECRI Institute. All Rights Reserved

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Ventilators, Intensive Care Product Comparison Chart

MODEL CARDINAL HEALTH/VIASYS HEALTHCARE Vela CARDINAL HEALTH/VIASYS HEALTHCARE Vela + CARDINAL HEALTH/VIASYS HEALTHCARE Vela Comprehensive COVIDIEN PURITAN BENNETT 740

PURCHASE INFORMATION List price Warranty Service Factory/on-site Training 3rd-party service Parts availability Delivery time, ARO Year first sold Number sold USA/worldwide Fiscal year OTHER SPECIFICATIONS

$13,995-17,995 2 years; 5 years or 40,000 hr on turbine Yes/yes Class at factory In some areas Yes 30-45 days 2002 Not specified/>10,000 July to June Low pressure (flowmeter); O2 inlet connection; synchronous nebulizer drive; touchscreen controls; onboard barometric pressure sensor; transport cart option with cylinder holders. 17429 October 2008

$13,995-17,995 2 years; 5 years or 40,000 hr on turbine Yes/yes Class at factory In some areas Yes 30-45 days 2002 Not specified/>10,000 July to June Low pressure (flowmeter); O2 inlet connection; synchronous nebulizer drive; touchscreen controls; onboard barometric pressure sensor; optional transport cart with cylinder holders. 17429 October 2008

$13,995-17,995 2 years; 5 years or 40,000 hr on turbine Yes/yes Class at factory In some areas Yes 30-45 days 2002 Not specified/>10,000 July to June Low pressure (flowmeter); O2 inlet connection; synchronous nebulizer drive; touchscreen controls; onboard barometric pressure sensor; optional transport cart with cylinder holders; optional capnography. 17429 October 2008

$14,790 2 years Yes/yes Yes Yes Yes 21 days 1997 Not specified October to September Integral O2 sensor; 2-5 hr battery backup; optional 7 hr external battery backup. Meets requirements of CISPR 11, CSA, IEC 60601-1, IEC 60601-2, IEC 60601-2-12, IEC 60601-212, and UL. 17429 October 2008

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

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Ventilators, Intensive Care Product Comparison Chart

MODEL COVIDIEN PURITAN BENNETT 760 Worldwide Yes Yes Adult, pediatric 40-2,000 3-150 5-80 1-70 0.2-8 >0.2 1:99 to 4:1 0-2 sec <30 sec 21-100 Yes 0-35 Yes (0-70) Yes Flow NA Yes/yes No 21-100 Rise time%, Esense% COVIDIEN PURITAN BENNETT 840 Worldwide Yes Yes Adult to neonatal 5-2,500 3-150 5-90 1-150 0.2-8 >0.2 1:99 to 4:1, 19:1 in bilevel/APRV 0-2 sec 0.5-3 sec automatic pause, <20 sec manual pause 21-100 Yes 0-45 0-70 Works with external nebulizers Pressure, flow 1.5 above flow sensor Yes/yes No 21-100 Rise time%, Esense% DRAEGER Carina home Worldwide No Yes Not specified 100-2,000 NA 5-50 0-50 5-50 NA 1:3 to 2:1 No No NA Yes 3-20 3-40 Yes Flow change, volume, pressure Not specified Yes/yes No No None specified DRAEGER Evita 2 dura Worldwide Yes Yes Adult, pediatric, neonatal 3-2,000 with NeoFlow 6-180 0-80 0-150 0.1-30 0.1-30 1:300 to 300:1 Yes Yes 21-100 Yes 0-35 0-80 Yes Flow, pressure Not specified Yes/yes Yes Yes None specified

WHERE MARKETED FDA CLEARANCE CE MARK (MDD) PATIENT TYPE CONTROLS Tidal volume, mL Inspiratory flow, L/min Inspiratory pressure, cm H2O Respiratory rate, bpm Inspiratory time, sec Expiratory time, sec IE ratio Inspiratory hold/plateau Expiratory hold FiO2, % Manual breath PEEP/CPAP, cm H2O Pressure support, cm H2O Nebulizer Trigger mechanism Bias/base flow range, L/min Pressure slope/ramp adjustment Sigh 100% O2 Others

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

©2008 ECRI Institute. All Rights Reserved

33

Ventilators, Intensive Care Product Comparison Chart

MODEL COVIDIEN PURITAN BENNETT 760 COVIDIEN PURITAN BENNETT 840 DRAEGER Carina home DRAEGER Evita 2 dura

OPERATING MODES Assist/control Volume breaths Pressure breaths SIMV Volume breaths SIMV Pressure breaths Pressure support Spontaneous/CPAP Pressure support Apnea-backup vent Combination modes Active/responsive valve Bilevel/APRV Others

Yes Yes Yes Yes Yes (0-70) Yes (0-70) Yes Not specified Not specified Not specified Speaking valve mode

Yes Yes Yes Yes Yes Yes Yes Yes, VV+ and VS Yes, active exhalation valve Yes NIV, PAV+

Yes Yes Yes Yes Yes Yes Yes Not specified Not specified Not specified I:E ratio 1:3 to 2:1, LPO only, no O2 control, 13 hr external battery extends battery operation time

Yes, AutoFlow Yes Yes Yes Yes Yes Yes Yes Yes Yes APRV, MMV, AutoFlow, PCV+, automatic tube compensation (all patient ranges), including nCPAP; optional noninvasive delivery and independent lung ventilation

MONITORED PARAMETERS Pressure PIP MAP PEEP Volume Tidal Minute Spontaneous minute FiO2 Respiratory rate Inspiratory time Expiratory time IE Others

Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Raw, Cstat, PEEPi, EEF

Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Rapid shallow breathing index, Ti/Ttot, Cstat, RAW, Pplat, respiratory mechanics (includes NIF, VC, P100, Rdyn, Cdyn, PEF, EEF, PSF, PAV+ with WOBpt and WOBtot), up to 53 parameters can be trended for 72 hr

Yes No No Yes No No No Yes No No No None specified

Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Optional occlusion pressure, NIF, RSBI, capnogram, new sensor, no calibration data, remote fault, transducer fault, resistance, compliance, breathing gas temperature, leak rate for minute volume

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Ventilators, Intensive Care Product Comparison Chart

MODEL COVIDIEN PURITAN BENNETT 760 Yes, ±10% of setting 0-50 L 3-60 cm H2O 10-90 cm H2O Not specified 10-60 sec Defaults to HP limit Not specified Yes Not specified Not specified Yes None specified COVIDIEN PURITAN BENNETT 840 Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes High exhaled tidal volume, low exhaled mandatory tidal volume, low exhaled spontaneous tidal volume, inspiration too long, high delivered O2, low delivered O2 Yes Yes Yes Yes Electronics and pneumatics Disconnect, occlusion, AC power loss, compressor inoperative, device alert, low battery, no air supply, no O2 supply, procedure error, screen block RS232 (2), nurse call Yes No Yes Yes No Yes DRAEGER Carina home No No No Yes No Yes Yes No Yes No No Yes High tidal volume DRAEGER Evita 2 dura Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes High tidal volume

PATIENT ALARMS FiO2 Low minute volume Low inspiratory pressure High pressure Loss of PEEP Apnea High continuous pressure/occlusion Inverse IE High respiratory rate High minute volume High PEEP Breathing circuit disconnect Others

EQUIPMENT ALARMS Gas supply failure Power failure Vent inoperative Low battery Self-diagnostics Others

Yes Yes Yes Yes Electronics and pneumatics Disconnect, occlusion

Yes Yes Yes Yes Yes Wrong patient system, rescue mode

Yes Yes Yes Yes Yes Exhalation valve, flow sensor insertion, leak, compliance

INTERFACING Output ports Remote alarm/display Analog output Report generation Display Hard copy Archival disk Network

RS232 (2), nurse call Yes No Optional Yes Yes Yes

RS232, analog Optional Yes Not specified Not specified Not specified Not specified

RS232, analog Optional Yes Via VentView Via VentView Via VentView Via VentView

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

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Ventilators, Intensive Care Product Comparison Chart

MODEL COVIDIEN PURITAN BENNETT 760 LCD Numbers, optional graphics Not specified Not specified Not specified NA O2 40-90 psi Piston 100-240 2.9 (115 VAC) 290 Yes 24 VDC, 7 A-h (not specified) 2.5 under normal conditions Yes 2.5-3 Yes 24 VDC, 17 A-h (not specified) 7 under normal conditions Yes 7.5-8 37.8 x 51.5 x 37 (14.9 x 20.3 x 14.6), 125.5 x 51.5 x 37 (49.4 x 20.3 x 14.6) with cart 30 (66.2) ventilator, 18 (39.7) cart COVIDIEN PURITAN BENNETT 840 Color LCD, touchscreen Numbers, graphics, waveforms, alarm violations Not specified Not specified Not specified Optional O2, air 35-100 psi Not specified 100-240 4.5 (120 VAC) 1,000 Yes 24 VDC, 6.5 A-h (not specified) 1 Yes 8 maximum No NA NA NA NA 33 x 45.7 x 25.4 (13 x 18 x 10) breath-delivery unit, 46 x 39.4 x 17 (18.1 x 15.5 x 6.7) graphical user interface, 99.8 x 58.2 x 60.2 (39.3 x 22.9 x 23.7) cart 18.2 (40.1) breath-delivery unit, 5.7 (12.6) graphical user interface, 15.5 (34.2) cart DRAEGER Carina home TFT BW Numbers, waveforms Not specified Not specified Not specified Not specified O2, air 500 hPa maximum Turbine 100-127/220-241 Not specified Not specified Yes Internal (not specified) 2 Yes 2 Yes Not specified (2) 13 Yes 8 27.5 x 17.5 x 38.5 (10.8 x 6.9 x 15.2) DRAEGER Evita 2 dura TFT color screen Numbers, waveforms, loops, trends Not specified Not specified Not specified Optional O2, air 2.7-6 bar, 40-87 psi Not specified 100-127/220-240 1.3 (230 VAC) maximum, 3.2 (100 VAC) maximum 125 Optional Internal (not specified) 2 Yes Not specified Yes Not specified (2) Not specified Not specified Not specified 29 x 53 x 45 (11.4 x 20.9 x 17.7); 131.5 x 58 x 66 (51.8 x 22.8 x 26) with trolley

DISPLAY TYPES DATA DISPLAYED MRI COMPATIBILITY SUITABLE FOR AIRCRAFT USE Approved by PNEUMATIC POWER Compressor Compressed gases Pressure ranges Turbine/piston LINE POWER, VAC Current, amps Watts INTERNAL BATTERY Type (number) Operating time, hr Rechargeable Recharging time, hr EXTERNAL BATTERY Type (number) Operating time, hr Rechargeable Recharging time, hr H x W x D, cm (in)

WEIGHT, kg (lb)

4.9 (10.8)

27 (59.5); 69 (152) with trolley and cabinet

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Ventilators, Intensive Care Product Comparison Chart

MODEL COVIDIEN PURITAN BENNETT 760 COVIDIEN PURITAN BENNETT 840 DRAEGER Carina home DRAEGER Evita 2 dura

PURCHASE INFORMATION List price Warranty Service Factory/on-site Training 3rd-party service Parts availability Delivery time, ARO Year first sold Number sold USA/worldwide Fiscal year OTHER SPECIFICATIONS

$19,522 2 years Yes/yes Yes Yes Yes 21 days 1998 Not specified October to September Exhalation sensitivity; risetime percentage; integral O2 sensor; 2-5 hr battery backup; optional 7 hr external battery backup. Meets requirements of CISPR 11, CSA, IEC 60601-1, IEC 60601-2, IEC 60601-2-12, and UL.

$33,417 2 years Yes/yes Yes Yes Yes 21 days 1998 Not specified October to September Noninvasive ventilation; respiratory mechanics; exhalation sensitivity; risetime percentage; integral O2 sensor; 30 min battery backup; trending package pending. Meets requirements of CISPR 11, CSA, IEC 60601-1, IEC 60601-2, IEC 60601-2-12, and UL.

$6,500 1 year Yes/yes Yes Yes Yes 4-6 weeks 2006 Not specified January to December All gas measurements under BTPS conditions. Meets requirements of IEC 60601.

$25,550 1 year Yes/yes Yes Yes Yes 4 weeks 1997 Not specified January to December All gas measurements under BTPS conditions; single-rotary-knob parameter adjustment; options and upgrades via software and/or hardware; compliance-compensated tubing system; open breathing system in all modes and patient ranges; optional SBCO2 (singlebreath CO2) and SpO2. Meets requirements of IEC 60601. 17429 October 2008

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

17429 October 2008

17429 October 2008

17429 October 2008

©2008 ECRI Institute. All Rights Reserved

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Ventilators, Intensive Care Product Comparison Chart

MODEL WHERE MARKETED FDA CLEARANCE CE MARK (MDD) PATIENT TYPE CONTROLS Tidal volume, mL Inspiratory flow, L/min Inspiratory pressure, cm H2O Respiratory rate, bpm Inspiratory time, sec Expiratory time, sec IE ratio Inspiratory hold/plateau Expiratory hold FiO2, % Manual breath PEEP/CPAP, cm H2O Pressure support, cm H2O Nebulizer Trigger mechanism Bias/base flow range, L/min Pressure slope/ramp adjustment Sigh 100% O2 Others DRAEGER Evita 4 Worldwide Yes Yes Adult, pediatric, neonatal 3-2,000 with NeoFlow 6-180 0-80 0-150 0.1-30 0.1-30 1:300 to 300:1 Yes Yes 21-100 Yes 0-35 0-80 Yes Flow, pressure Not specified Yes/yes Yes Yes None specified DRAEGER Evita XL Worldwide Yes Yes Adult, pediatric, neonatal 3-2,000 with NeoFlow 6-180 0-95 0-300 0.1-30 0.1-30 1:300 to 300:1 Yes Yes 21-100 Yes 0-50 0-80 Yes Flow, pressure Not specified Yes/yes Yes Yes None specified DRAEGER Oxylog 3000 Worldwide Submitted Yes Not specified 50-2,000 100 maximum 0-55 2-60 0.2-10 Not specified 1:4 to 3:1 Yes No 40-100 Yes 0-20 0-35 above PEEP Not specified Flow Not specified Yes/yes Not specified Yes O2 inhalation (0-15 L/min O2) DRAEGER Savina Worldwide Yes Yes Adult, pediatric, neonatal 50-2,000 Not specified 0-99 2-80 0.2-10 Not specified 1:150 to 150:1 Yes No 21-100 Yes 0-35 0-70 Yes Flow, pressure Not specified Yes/yes Yes Yes 5-200 mbar/sec flow acceleration

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

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Ventilators, Intensive Care Product Comparison Chart

MODEL OPERATING MODES Assist/control Volume breaths Pressure breaths SIMV Volume breaths SIMV Pressure breaths Pressure support Spontaneous/CPAP Pressure support Apnea-backup vent Combination modes Active/responsive valve Bilevel/APRV Others DRAEGER Evita 4 DRAEGER Evita XL DRAEGER Oxylog 3000 DRAEGER Savina

Yes, AutoFlow Yes Yes Yes Yes Yes Yes Yes Yes Yes APRV, MMV, AutoFlow, PCV+, automatic tube compensation (all patient ranges) with nCPAP; optional noninvasive delivery and independent lung ventilation

Yes, AutoFlow Yes Yes Yes Yes Yes Yes Yes Yes Yes SmartCare (knowledgebased weaning system), APRV, MMV, AutoFlow, PCV+, automatic tube compensation (all patient ranges) with nCPAP, optional noninvasive delivery and independent lung ventilation

Yes Not specified Yes Yes Yes Yes Yes Not specified Not specified Not specified PCV+, noninvasive delivery possible for CPAP and PCV+

Yes, AutoFlow Yes Yes Yes Yes Yes Yes Yes Yes No AutoFlow, PCV+, nCPAP, all modes have noninvasive delivery option

MONITORED PARAMETERS Pressure PIP MAP PEEP Volume Tidal Minute Spontaneous minute FiO2 Respiratory rate Inspiratory time Expiratory time IE Others

Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Optional occlusion pressure, NIF, RSBI, capnogram, new sensor, no calibration data, remote fault, transducer fault, resistance, compliance, breathing gas temperature, leak rate for minute volume

Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Optional occlusion pressure, NIF, RSBI, capnogram, new sensor, no calibration data, remote fault, transducer fault, resistance, compliance, breathing gas temperature, leak rate for minute volume

Yes Yes Yes Yes Yes Yes Yes Yes Not specified Not specified Not specified Plateau pressure, spontaneous respiratory rate

Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Plateau time, compliance, resistance, breathing gas temperature, leak rate for minute volume

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

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Ventilators, Intensive Care Product Comparison Chart

MODEL PATIENT ALARMS FiO2 Low minute volume Low inspiratory pressure High pressure Loss of PEEP Apnea High continuous pressure/occlusion Inverse IE High respiratory rate High minute volume High PEEP Breathing circuit disconnect Others EQUIPMENT ALARMS Gas supply failure Power failure Vent inoperative Low battery Self-diagnostics Others INTERFACING Output ports Remote alarm/display Analog output Report generation Display Hard copy Archival disk Network DRAEGER Evita 4 Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes High tidal volume Yes Yes Yes Yes Yes Exhalation valve, flow sensor insertion, leak, compliance RS232, analog Optional Yes Via VentView Via VentView Via VentView Via VentView DRAEGER Evita XL Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes High tidal volume Yes Yes Yes Yes Yes Exhalation valve, flow sensor insertion, leak, compliance RS232, analog Optional Yes Via VentView Via VentView Via VentView Via VentView DRAEGER Oxylog 3000 Yes Yes Yes Yes Yes Yes Yes Not specified Yes Yes Not specified Yes None specified Yes Yes Yes Yes Yes Leakage, flow sensor DRAEGER Savina Yes Yes Yes Yes Yes Yes Yes Not specified Yes Yes Yes Yes High tidal volume Yes Yes Yes Yes Yes Exhalation valve, flow sensor insertion, leak RS232, analog Optional No Via optional graphic screen Via optional graphic screen Via optional graphic screen Via optional graphic screen

IrDA RS232 Not specified Not specified Integrated EL display Not specified Via Customer Service Mode Not specified

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Ventilators, Intensive Care Product Comparison Chart

MODEL DISPLAY TYPES DATA DISPLAYED DRAEGER Evita 4 TFT color touchscreen Numbers, waveforms, loops, trends Not specified Not specified Not specified Optional O2, air 2.7-6 bar, 40-87 psi Not specified 100-127/220-240 1.3 (230 VAC) maximum, 3.2 (100 VAC) maximum 125 Optional Internal (not specified) 2 Yes Not specified Yes Not specified (2) Not specified Not specified Not specified 29 x 53 x 45 (11.4 x 20.9 x 17.7); 131.5 x 58 x 66 (51.8 x 22.8 x 26) with trolley 27 (59.5); 69 (152) with trolley and cabinet DRAEGER Evita XL TFT color touchscreen Numbers, waveforms, loops, trends, short trends Not specified Not specified Not specified Optional O2, air 2.7-6 bar, 40-87 psi Not specified 100-127/220-240 1.3 (230 VAC) maximum, 3.2 (100 VAC) maximum 125 Optional Internal (not specified) 2 Yes Not specified Yes Not specified (2) Not specified Not specified Not specified 29 x 53 x 45 (11.4 x 20.9 x 17.7); 133.5 x 58 x 66 (52.5 x 22.8 x 26) with trolley 27 (59.5); 69 (152) with trolley and cabinet DRAEGER Oxylog 3000 EL; 9 languages; adjustable Settings, alarms, measured values, pressure and flow waveforms, stored events and alarms Not specified Not specified Not specified Not specified/not integrated O2 2.7-6 bar, 39-90 psi Not specified 100-240 2.1, maximum 3.8 40 Yes Lithium ion or Ni-MH (not specified) ~4 (lithium ion), 3 (Ni-MH) Yes ~5 (lithium ion), 4 (Ni-MH) Not specified Not specified Not specified Not specified Not specified 18.4 x 28.5 x 17.5 (7.2 x 11.1 x 6.9) 5.4 (11.9) DRAEGER Savina Black-and-white LCD Numbers, waveforms, bar graph Not specified Not specified Not specified Built-in blower (turbine) O2 2.7-6 bar, 40-87 psi Yes/no 100-240 1.3 (230 VAC) maximum, 3.4 (100 VAC) maximum 75 Standard Lead gel (not specified) 1 Yes 2 Yes Lead or lead gel (not specified) 4 Yes 15 38 x 38 x 36 (15 x 15 x 14), 137 x 55 x 56 (53 x 22 x 22) with trolley 24 (53)

MRI COMPATIBILITY SUITABLE FOR AIRCRAFT USE Approved by PNEUMATIC POWER Compressor Compressed gases Pressure ranges Turbine/piston LINE POWER, VAC Current, amps Watts INTERNAL BATTERY Type (number) Operating time, hr Rechargeable Recharging time, hr EXTERNAL BATTERY Type (number) Operating time, hr Rechargeable Recharging time, hr H x W x D, cm (in) WEIGHT, kg (lb)

This is the fourth of five pages covering the above model(s). These specifications continue onto the next page.

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Ventilators, Intensive Care Product Comparison Chart

MODEL PURCHASE INFORMATION List price Warranty Service Factory/on-site Training 3rd-party service Parts availability Delivery time, ARO Year first sold Number sold USA/worldwide Fiscal year OTHER SPECIFICATIONS DRAEGER Evita 4 DRAEGER Evita XL DRAEGER Oxylog 3000 DRAEGER Savina

$31,130 1 year Yes/yes Yes Yes Yes 4 weeks 1996 Not specified January to December Evita 2 platform plus touchscreen, ideal-bodyweight setting, and cursor in displayed graphics.

$36,230 1 year Yes/yes Yes Yes Yes 4 weeks 2002 Not specified January to December Evita 4 platform plus screen customization (vent check sheet, waveforms, displayed values), multiple graphic capabilities (short trends, up to 6 loops, combined cursor for simultaneous loop and wave analysis); online information for modes and alarms; lung protection package includes slow-flow inflection maneuver; lung recruitment trending and direct link for pressure changes in pressure control. 17429 October 2008

Not specified 1 year Yes/yes Yes Yes Yes Not specified 2003 Not specified January to December Transport ventilator; suitable for outdoor use (temperature range -18 to +50°C [-4 to +122°F], relative humidity 5-95%, ambient pressure 570-1,200 hPa). Vibration tested according to MIL STD 810 F (method 514.5); airworthiness according to RTCA D-160D (section 7 and 8) IPX4.

$13,699 1 year Yes/yes Yes Yes Yes 4 weeks 2000 Not specified January to December All gas measurements under BTPS conditions; single-rotary-knob parameter adjustment; options and upgrades via software and/or hardware; open breathing system in all modes and patient ranges; low-pressure O2 (LPO) inlet. Meets requirements of IEC 60601.

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

17429 October 2008

17429 October 2008

17429 October 2008

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©2008 ECRI Institute. All Rights Reserved.

Ventilators, Intensive Care Product Comparison Chart

MODEL eVENT MEDICAL Inspiration LS1 Worldwide Yes Yes Adult, pediatric, infant 5-2,000 0-120 mandatory 0-80 1-150 0.1-10 0.2-59.8 in SPAP 59.9:1 to 1:10 0-70% or manual Manual up to 30 sec 21-100 Yes 0-50 0-80 Yes Flow, pressure Autoset, 2 above flow sensitivity setting Fast, medium, slow Programmable, pressure or volume ventilation Yes Flow pattern (square, 50% decel, decel), rise time (fast, medium, slow), exhalation sensor, SPAP (Phigh, Plow, Pshigh, Pslow, Thigh, Tlow), sigh GE HEALTHCARE (DATEX-OHMEDA) Centiva/5 Worldwide1 Yes Yes Adult to pediatric, optional neonatal 20-2,000 2-99.6, 180 maximum peak flow 1-59 4-100 0.06-13.6, set via rate and I:E ratio 0.2-13.6, set via rate and I:E ratio 1:9 to 4:1, 9:1 in bilevel Yes Yes 21-100 Yes Off, 2-35 0-59 Pneumatic, synchronized, compensated Flow 3-30 Rise-time adjustment for inspiratory pressure and pressure support No Yes, suction maneuver None specified GE HEALTHCARE (DATEX-OHMEDA) Engström Carestation Worldwide Yes Yes Adult to pediatric, optional neonatal 20-2,000 adult, 2-350 neonatal 2-160 adult, 2-90 pediatric, 0.5-30 neonatal, 200 maximum peak flow 1-98 3-120 for control modes, 160 for support modes 0.25-15 adult, 0.1-10 neonatal 0.25-59.75 1:79 to 4:1, 60:1 adult and pediatric, 40:1 neonatal in bilevel 2-15 sec 2-20 sec 21-100 Yes Off, 1-50 0-60 Built-in Aeroneb Pro nebulizer system Pressure, flow 2-10, 8-20 NIV Rise-time adjustment for pressure, flow, and pressure support No Yes, suction maneuver Thigh, Tlow, Tsupp, trigger window, end flow GE HEALTHCARE (DATEX-OHMEDA) Engström Pro Worldwide Yes Yes Adult to pediatric 20-2,000 2-160 adult, 2-90 pediatric, 200 maximum peak flow 1-98 3-120 for control modes, 160 for support modes 0.25-15 0.25-59.75 1:79 to 4:1, 60:1 adult and pediatric in bilevel 2-15 sec 2-20 sec 21-100 Yes Off, 1-50 0-60 Built-in Aeroneb Solo nebulizer system Pressure, flow 2-10, 8-20 NIV Rise-time adjustment for pressure, flow, and pressure support No Yes, suction maneuver Thigh, Tlow, Tsupp, trigger window, end flow

WHERE MARKETED FDA CLEARANCE CE MARK (MDD) PATIENT TYPE CONTROLS Tidal volume, mL Inspiratory flow, L/min Inspiratory pressure, cm H2O Respiratory rate, bpm Inspiratory time, sec Expiratory time, sec IE ratio Inspiratory hold/plateau Expiratory hold FiO2, % Manual breath PEEP/CPAP, cm H2O Pressure support, cm H2O Nebulizer Trigger mechanism Bias/base flow range, L/min Pressure slope/ramp adjustment Sigh 100% O2 Others

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

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43

Ventilators, Intensive Care Product Comparison Chart

MODEL eVENT MEDICAL Inspiration LS1 OPERATING MODES Assist/control Volume breaths Pressure breaths SIMV Volume breaths SIMV Pressure breaths Pressure support Spontaneous/CPAP Pressure support Apnea-backup vent Combination modes Active/responsive valve Bilevel/APRV Others GE HEALTHCARE (DATEX-OHMEDA) Centiva/5 GE HEALTHCARE (DATEX-OHMEDA) Engström Carestation GE HEALTHCARE (DATEX-OHMEDA) Engström Pro

Yes Yes Yes Yes Yes Yes Yes PRVC, VS PSOL and PSOL active exhalation valve SPAP Auto mode, NIV, volume support, PRVC, nCPAP, nCPAP+

Yes Bilevel Yes Bilevel Yes Yes Yes Yes Yes, active exhalation valve Yes Bilevel, bilevel with volume guarantee

Yes Yes Yes Yes Yes Yes Yes Yes Yes, active exhalation valve Yes Bilevel, pressure control with volume guarantee, SIMV-PCVG, bilevel-VG, noninvasive, NeoCPAP

Yes Yes Yes Yes Yes Yes Yes Yes Yes, active exhalation valve Yes Bilevel, pressure control with volume guarantee, SIMV-PCVG, bilevel-VG, noninvasive

MONITORED PARAMETERS Pressure PIP MAP PEEP Volume Tidal Minute Spontaneous minute FiO2 Respiratory rate Inspiratory time Expiratory time IE Others

Yes Yes Yes Yes Yes Yes Yes Yes Yes No Yes Spontaneous rate, Ti/Ttot, RSBI, Cstat, RR, spontaneous% L/hr, spontaneous% 8h, Pplat, % leak, high-low ratio, PEEP, VTi, Heliox, inspiratory resistance, expiratory resistance (outside USA)

Yes Yes Yes Yes Yes Yes Yes Yes No No No Compliance, resistance, Pmin, RSBI, PEEPi, 12-day data, ventilator settings and alarm settings trends, alarm and event log

Yes Yes Yes, PEEPe and PEEPi Yes Yes Yes Yes Yes Yes Yes Yes Functional residual capacity (FRC), SpiroDynamics, patient spirometry, auxiliary pressure, patient flow, CO2, compliance, resistance, RQ, VO2, VCO2, RSBI, energy expenditure, 14-day trending, alarm logs

Yes Yes Yes, PEEPe and PEEPi Yes Yes Yes Yes Yes Yes Yes Yes Patient spirometry, auxiliary pressure, compliance, resistance, RSBI, 14-day trending, alarm logs

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Ventilators, Intensive Care Product Comparison Chart

MODEL eVENT MEDICAL Inspiration LS1 PATIENT ALARMS FiO2 Low minute volume Low inspiratory pressure High pressure Loss of PEEP Apnea High continuous pressure/occlusion Inverse IE High respiratory rate High minute volume High PEEP Breathing circuit disconnect Others Yes (high and low) Yes Yes Yes Yes (nCPAP, nCPAP+) Yes Yes Yes Yes No No Yes High and low MAP, % leak, low respiratory rate, Vti high, high and low Vte GE HEALTHCARE (DATEX-OHMEDA) Centiva/5 Yes Yes Yes Yes Yes, indirectly Yes Yes Visual Yes Yes No Yes Low respiratory rate GE HEALTHCARE (DATEX-OHMEDA) Engström Carestation Yes Yes Yes Yes Yes Yes Yes Ventilation limit indicator Yes Yes Yes Yes Low respiratory rate, high/low tidal volume, high intrinsic PEEP, ETCO2, ETO2, ventilator soft-limit indicators Yes Yes Yes Yes Yes Flow sensor, circuit leak, patient connect, patient disconnect, occlusion, escalating alarms RS232, RS485, RS422, 2 USB ports, Ethernet, PC Flash card slot Yes, nurse call Yes Via N-DISVENT or Unity link Via N-DISVENT or Unity link Via N-DISVENT, Unity link, or PC Flash card slots Yes GE HEALTHCARE (DATEX-OHMEDA) Engström Pro Yes Yes Yes Yes Yes Yes Yes Ventilation limit indicator Yes Yes Yes Yes Low respiratory rate, high/low tidal volume, high intrinsic PEEP, ventilator soft-limit indicators Yes Yes Yes Yes Yes Flow sensor, circuit leak, patient connect, patient disconnect, occlusion, escalating alarms RS232, RS485, RS422, 2 USB ports, Ethernet, PC Flash card slot Yes, nurse call Yes Via N-DISVENT or Unity link Via N-DISVENT or Unity link Via N-DISVENT, Unity link, or PC Flash card slots Yes

EQUIPMENT ALARMS Gas supply failure Power failure Vent inoperative Low battery Self-diagnostics Others

Yes Yes Yes Yes Yes Automatic calibrations and extensive logging of technical faults RS232, Ethernet, nurse call Miniweb, Virtual Report Viewing System Nurse call Miniweb, Virtual Report Viewing System Miniweb, Virtual Report Viewing System Miniweb, Virtual Report Viewing System Miniweb, Virtual Report Viewing System

Yes Yes Yes Yes Yes Flow sensor, circuit leak, patient connect, patient disconnect RS232 Yes, nurse call No Via N-DISVENT Via N-DISVENT Via RS232 to external PC No

INTERFACING Output ports Remote alarm/display Analog output Report generation Display Hard copy Archival disk Network

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

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45

Ventilators, Intensive Care Product Comparison Chart

MODEL eVENT MEDICAL Inspiration LS1 Graphical user interface SVGA All ventilator data GE HEALTHCARE (DATEX-OHMEDA) Centiva/5 30.5 cm (12") diagonal color touchscreen LCD Real-time pressure and flow waveforms, measured numerics, loops, settings, status Not specified Not specified Not specified Optional O2, air 40-80 psi, 280-600 kPa Not specified 98-132, 207-253; 50/60 Hz Not specified <50 Yes Sealed lead-acid (2) 0.5 Yes 12 (full discharge) Yes Sealed lead-acid (2) in special battery pack 1 Yes 10 32 x 32 x 32 (12.6 x 12.6 x 12.6) CMS, 25 x 24 (9.8 x 9.4) footprint 14.7 (32.3) GE HEALTHCARE (DATEX-OHMEDA) Engström Carestation Color LCD 30.5 cm (12") Real-time graphics, numbers, 6 waveforms, 3 loops, graphic and numeric trends, minitrends, snapshot, split screens Not specified Not specified Not specified Optional O2, air 35-94 psi, 240-641 kPa Not specified 85-132, 187-264; 47/63 Hz <1.7 (120 VAC), <0.87 (230 VAC) <200 Yes Sealed lead-acid (2) 0.5-2 Yes 8 (full discharge) Not specified Not specified Not specified Not specified Not specified 123 x 38 x 36 (48.4 x 15 x 14) with trolley and display down; 144 x 38 x 36 (56.8 x 15 x 14) with trolley and display up 29 (64), 66 (145) with trolley GE HEALTHCARE (DATEX-OHMEDA) Engström Pro Color LCD 30.5 cm (12") Real-time graphics, numbers, 6 waveforms, 3 loops, graphic and numeric trends, minitrends, snapshot, split screens Not specified Not specified Not specified Optional O2, air 35-94 psi, 240-641 kPa Not specified 85-132, 187-264; 47/63 Hz <1.7 (120 VAC), <0.87 (230 VAC) <200 Yes Sealed lead-acid (2) 0.5-2 Yes 8 (full discharge) Not specified Not specified Not specified Not specified Not specified 123 x 38 x 36 (48.4 x 15 x 14) with trolley and display down; 144 x 38 x 36 (56.8 x 15 x 14) with trolley and display up 29 (64), 66 (145) with trolley

DISPLAY TYPES DATA DISPLAYED

MRI COMPATIBILITY SUITABLE FOR AIRCRAFT USE Approved by PNEUMATIC POWER Compressor Compressed gases Pressure ranges Turbine/piston LINE POWER, VAC Current, amps Watts INTERNAL BATTERY Type (number) Operating time, hr Rechargeable Recharging time, hr EXTERNAL BATTERY Type (number) Operating time, hr Rechargeable Recharging time, hr H x W x D, cm (in)

No Not specified Not specified Internal backup O2, air, heliox 2-6 bar NA 100-240, 50/60 Hz 1.4 120 Yes Lead-acid (2) 5, 2 with internal compressor Yes 4, depends on charge level Optional Lead-acid (1 or 2) 13, 5 with internal compressor Yes 6, depends on charge level 53 x 40 x 40 (21 x 16 x 16)

WEIGHT, kg (lb)

24 (53)

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46

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Ventilators, Intensive Care Product Comparison Chart

MODEL eVENT MEDICAL Inspiration LS1 PURCHASE INFORMATION List price Warranty Service Factory/on-site Training 3rd-party service Parts availability Delivery time, ARO Year first sold Number sold USA/worldwide Fiscal year OTHER SPECIFICATIONS GE HEALTHCARE (DATEX-OHMEDA) Centiva/5 GE HEALTHCARE (DATEX-OHMEDA) Engström Carestation GE HEALTHCARE (DATEX-OHMEDA) Engström Pro

$24,000 5 years, parts and PM kit Yes/yes Yes Yes Yes Not specified 2003 Not specified/>3,000 January to December Touchscreen; biomed training tuition; Internet capable MiniWeb and Virtual Report; heliox delivery.

Not specified 1 year, parts and labor Yes/yes Yes Yes Yes 30-45 days 2005 Not specified January to December Display tilts for better visibility when ventilator is pendant mounted and can be remotely mounted; automatic suction procedure, NIV capable; automatic patient detection; airway-resistance compensation.

Not specified 1 year, parts and labor Yes/yes Yes Yes Yes 30-45 days 2004 Not specified January to December Spontaneous Breathing Trial (SBT); nondepleting paramagnetic O2 sensor; user-customizable default settings; escalating highpriority alarm; NIV mode; automatic patient detection; snapshot; airway-resistance compensation; programmable mode families; optional module bay provides enhanced respiratory monitoring. 17429 October 2008

Not specified 1 year, parts and labor Yes/yes Yes Yes Yes 30-45 days 2008 Not specified January to December Spontaneous Breathing Trial (SBT); nondepleting paramagnetic O2 sensor; user-customizable default settings; escalating highpriority alarm; NIV mode; automatic patient detection; snapshot; airway-resistance compensation; programmable mode families. 17429 October 2008

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

17429 October 2008

1LS

17429 October 2008

1Bilevel

stands for large screen. VG not currently available in Canada and USA.

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47

Ventilators, Intensive Care Product Comparison Chart

MODEL WHERE MARKETED FDA CLEARANCE CE MARK (MDD) PATIENT TYPE CONTROLS Tidal volume, mL Inspiratory flow, L/min Inspiratory pressure, cm H2O Respiratory rate, bpm Inspiratory time, sec Expiratory time, sec IE ratio Inspiratory hold/plateau Expiratory hold FiO2, % Manual breath PEEP/CPAP, cm H2O Pressure support, cm H2O Nebulizer Trigger mechanism Bias/base flow range, L/min Pressure slope/ramp adjustment Sigh 100% O2 Others HAMILTON MEDICAL G5 Worldwide Yes Yes Adult, pediatric, neonatal 2-2,000 1-180 0-100 above PEEP 1-150 0.05-10 0.2-59.9 1:9 to 4:1, 150:1 in APRV mode 10 sec maximum 10 sec maximum 21-100 Yes 0-50 0-100 Yes, inspiratory, expiratory or continuous with timer Pressure/flow 4-30, automatic 25-200 msec Yes Yes % tube resistance compensation, tube type/size, PV curve/recruitment maneuver controls, Thigh/Tlow/Phigh/Plow for APRV mode, ASV controlsPT height, %VE, PSV mode-ETS/flow cycle, maximum inspiratory time HAMILTON MEDICAL GALILEO GOLD Worldwide Yes Yes Adult, pediatric, neonatal 10-2,000 1-180 0-100 above PEEP 1-120 0.1-10 0.2-59.9 1:9 to 4:1, 150:1 in APRV mode 10 sec maximum 10 sec maximum 21-100 Yes 0-50 0-100 Yes, inspiratory, expiratory or continuous with timer Pressure/flow 1-30, automatic 25-200 msec Yes Yes % tube resistance compensation, tube type/size, PV curve/recruitment maneuver controls, Thigh/Tlow/Phigh/Plow for APRV mode, ASV controlsPT height, %VE, PSV mode-ETS/flow cycle, maximum inspiratory time HAMILTON MEDICAL RAPHAEL XTC Worldwide Yes Yes Adult, pediatric 50-2,000 0-180 0-50 above PEEP/CPAP 0-99 0.1-9.6 0.2-60 1:9 to 4:1, 150:1 IN APRV mode 15 sec maximum NA 21-100 Yes 0-35 0-50 above PEEP/CPAP Yes, Inspiratory Flow 1-10, automatic 50-200 msec Yes Yes % tube resistance compensation, tube type/size, Thigh/Tlow/Phigh/Plow for APRV mode, ASV controlsPT height, %VE, PSV mode-ETS/flow cycle, maximum inspiratory time IMPACT Uni-Vent 754 Worldwide Yes Yes Adult, pediatric, infant 0-3,000 0-60 15-100 1-150 0.1-3 NA 1:1 to 1:600 Yes No 21-100 Yes 0-20 No No Pressure NA Yes/yes Yes Not specified None specified

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Ventilators, Intensive Care Product Comparison Chart

MODEL OPERATING MODES Assist/control Volume breaths Pressure breaths SIMV Volume breaths SIMV Pressure breaths Pressure support Spontaneous/CPAP Pressure support Apnea-backup vent Combination modes Active/responsive valve Bilevel/APRV Others MONITORED PARAMETERS Pressure PIP MAP PEEP Volume Tidal Minute Spontaneous minute FiO2 Respiratory rate Inspiratory time Expiratory time IE Others HAMILTON MEDICAL G5 HAMILTON MEDICAL GALILEO GOLD HAMILTON MEDICAL RAPHAEL XTC IMPACT Uni-Vent 754

Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes ASV, NIV

Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes ASV, NIV

Yes (target Vt) Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes ASV, NIV

Yes No Yes No No No No Yes No No No None specified

Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Ventilation cockpit with dynamic lung gives realtime visualization of the lungs, vent status gives visual representation of ventilator dependency, static compliance, inspiratory/expiratory resistance, inspiratory/expiratory time constant, patient trigger, PO.1, RSBI (f/Vt), WOB, pressure-time product, auxiliary pressure, minimum pressure, Vleak, %O2, PVtool, inspiratory/expiratory PV curves/recruitment tool, CO2 measurements by optional mainstream CO2 sensor

Yes Yes Yes Yes No No Yes Yes Yes Yes Yes Ventilation cockpit with ASV safety window, static compliance, inspiratory/expiratory resistance, inspiratory/expiratory time constant, patient trigger, PO.1, RSBI (f/Vt), WOB, pressure-time product, air trapping, auxiliary pressure, minimum pressure, Vleak, %O2, PVtool, inspiratory/expiratory PV curves/recruitment tool

Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Ventilation cockpit with ASV safety window, AutoPEEP, static compliance; inspiratory/expiratory flow, inspiratory/expiratory time constant, leak (%)

Yes Yes Yes Yes No No Yes Yes Yes No Yes None specified

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

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Ventilators, Intensive Care Product Comparison Chart

MODEL PATIENT ALARMS FiO2 Low minute volume Low inspiratory pressure High pressure Loss of PEEP Apnea High continuous pressure/occlusion Inverse IE High respiratory rate High minute volume High PEEP HAMILTON MEDICAL G5 Yes Yes Yes Yes Yes Yes Yes Not specified Yes Yes Not specified HAMILTON MEDICAL GALILEO GOLD Yes Yes Yes Yes Yes Yes Yes Text message Yes Yes Not specified HAMILTON MEDICAL RAPHAEL XTC Yes Yes Automatic Yes Yes Yes Yes User message Yes Yes Yes, monitored PEEP/CPAP >set PEEP/CPAP + 5 cm H2O for 2 consecutive breaths Yes Pressure limitation, high pressure during sigh, exhalation obstructed, disconnection, volume measurement inaccurate. Various 'check controls' (settings conflicts), "cannot meet target" in combination modes Yes Yes Yes Yes Yes Obstruction, maximum leak RS232C, analogue call bell Yes Yes Event log real time, exportable via flash card 10.4" LCD Via software computer interface Event log-on Flash drive Not specified IMPACT Uni-Vent 754 No No Yes Yes Yes Yes Yes Yes No No Yes

Breathing circuit disconnect Others

Yes Low respiratory rate, low tidal volume, exhalation obstruction, maximum leak compensation, pressure limitation, check Ti, check %VE, High/low PetCO (optional), various check controls (settings conflicts), "cannot meet target" in combination modes Yes Yes Yes Yes Yes Technical faults RS232C, Flash drive, USB port, analogue call bell Yes Yes Event log real time, exportable via flash card 15" LCD Via software computer interface Flash drive, USB port Not specified

Yes Low respiratory rate, low tidal volume, exhalation obstruction, maximum leak compensation, pressure limitation, check Ti, check %VE, air trapping, various check controls (settings conflicts), "cannot meet target" in combination modes Yes Yes Yes Yes Yes Technical faults RS232C analogue call bell Yes Yes Event log real time, exportable via flash card 10.7" LCD Via software computer interface Event log-on Flash drive Not specified

Yes None specified

EQUIPMENT ALARMS Gas supply failure Power failure Vent inoperative Low battery Self-diagnostics Others INTERFACING Output ports Remote alarm/display Analog output Report generation Display Hard copy Archival disk Network

Yes Yes Yes Yes Yes None specified RS232 No No No No No No

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Ventilators, Intensive Care Product Comparison Chart

MODEL DISPLAY TYPES DATA DISPLAYED HAMILTON MEDICAL G5 Color touchscreen, LCD TFT Dynamic lung, vent status, real-time graphics, numerics, waveforms, loops, trends No Not specified Not specified Optional O2, air, Heliox 29-86 psi No 100-240 2.7 210 maximum Yes Sealed lead-acid (1) 1 (1/each optional hotswappable extended battery) Yes 7 minimum Optional Lithium Ion hot swappable (not specified) 1 minimum Yes 7 minimum 150 x 64 x 60 (59 x 25.2 x 23.6) standard trolley, 44 x 50 x 45 (17.3 x 19.7 x 17.7) shelf mount 57 (125.7) trolley, 42 (92.6) shelf mount HAMILTON MEDICAL GALILEO GOLD Color screen, LCD, TFT ASV graphics, real-time graphics, numerics, waveforms, loops, trends No Not specified Not specified Optional O2, air 29-86 psi No 100-240 2.3 (100 VAC), 1 (240 VAC) 230 maximum Yes Sealed lead-acid (1) 1 minimum Yes 6 No NA NA NA NA 44 x 62 x 154 (17.3 x 24.5 x 61) with standard trolley 48 (105.8) HAMILTON MEDICAL RAPHAEL XTC Color screen, LCD, TFT ASV graphics, real-time graphics, waveforms, numerics, loops, trends No Not specified Not specified Optional O2, air 29-86 psi No 100-240 0.7 (120 VAC) 40 VA Yes Sealed lead-acid (1) 1 minimum Yes 6 No NA NA NA NA 33 x 53 x 42 (13 x 20.9 x 16.5) 18 (40) IMPACT Uni-Vent 754 LED, LCD Numbers, graphics, waveforms, alarms With extended circuit Yes Not specified Yes O2 40-80 psi Not specified 95-265 autosensing 5 60 Yes Sealed lead-acid gel cell (not specified) 3-6 with compressor, 9 gas supplied Yes 16, 4 with optional rapid charger Not specified Not specified Not specified Not specified Not specified 29.2 x 23.5 x 12.4 (11.5 x 9.3 x 4.9) 5.8 (12.8)

MRI COMPATIBILITY SUITABLE FOR AIRCRAFT USE Approved by PNEUMATIC POWER Compressor Compressed gases Pressure ranges Turbine/piston LINE POWER, VAC Current, amps Watts INTERNAL BATTERY Type (number) Operating time, hr Rechargeable Recharging time, hr EXTERNAL BATTERY Type (number) Operating time, hr Rechargeable Recharging time, hr H x W x D, cm (in)

WEIGHT, kg (lb)

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Ventilators, Intensive Care Product Comparison Chart

MODEL PURCHASE INFORMATION List price Warranty Service Factory/on-site Training 3rd-party service Parts availability Delivery time, ARO Year first sold Number sold USA/worldwide Fiscal year OTHER SPECIFICATIONS HAMILTON MEDICAL G5 HAMILTON MEDICAL GALILEO GOLD HAMILTON MEDICAL RAPHAEL XTC IMPACT Uni-Vent 754

Not specified Not specified Yes/yes Yes Yes Yes 45-60 days 2008 Not specified December to November O2 analyzer; smart apnea backup; proximal airway monitoring; TRC automatic tube compensation; PV tool; automated compliance curve with both inspiratory and expiratory limbs; ventilation analyzer window. Meets requirements of ANSI Z79.10-1979/Z797-1976, CSA, DIN 13254, GLEM, IEC 60601 and 62D/60601, ISO 121/5359/5369/7767, JMMI, NFC 74-350, SEV, SETI, ORKI, VTT, and TUV. 17429 October 2008

Not specified Not specified Yes/yes Yes Yes Yes 45-60 days 2005 Not specified December to November O2 analyzer; smart apnea backup; proximal airway monitoring; TRC automatic tube compensation; PV tool; automated compliance curve with both inspiratory and expiratory limbs; ventilation analyzer window. Meets requirements of ANSI Z79.10-1979/Z797-1976, CSA, DIN 13254, GLEM, IEC 60601 and 62D/60601, ISO 121/5359/5369/7767, JMMI, NFC 74-350, SEV, SETI, ORKI, VTT, and TUV. 17429 October 2008

Not specified Not specified Yes/yes Yes Yes Yes 45-60 days 2006 Not specified December to November Meets requirements of ANSI Z79.10-1979/Z797-1976, CSA, DIN 13254, GLEM, IEC 60601 and 62D/60601, ISO 121/5359/5369/7767, JMMI, NFC 74-350, SEV, and TUV.

$8,995 1 year Yes/per contract Yes No Yes Stock to 30 days 1997 Not specified January to December Includes built-in air/O2 mixer and compressor; altitude and PEEP compensation; automatic backlighting of LCD; graphics display pressure waveform; internal backup ventilator.

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

17429 October 2008

17429 October 2008

52

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Ventilators, Intensive Care Product Comparison Chart

MODEL WHERE MARKETED FDA CLEARANCE CE MARK (MDD) PATIENT TYPE CONTROLS Tidal volume, mL Inspiratory flow, L/min Inspiratory pressure, cm H2O Respiratory rate, bpm Inspiratory time, sec Expiratory time, sec IE ratio Inspiratory hold/plateau Expiratory hold FiO2, % Manual breath PEEP/CPAP, cm H2O Pressure support, cm H2O Nebulizer IMPACT Uni-Vent EMV+ Worldwide Yes No Adult, pediatric, infant 50-1,500 0 to 100 10-60, 80 with confirmation 0-60 0.3-3 NA 1:1 to 1:10 No No 21-100 Yes 0-25 0-40 No INTERMED INTER 5 PLUS/GMX Worldwide No Yes Adult, pediatric, neonatal 10-2,000 2-120 (controlled), 0-150 (demand) 5-80 0-180 0.1-15 0.1 minimum (indirectly adjustable) 1:99 to 9.9:1 (indirectly adjustable) Manual (15 sec maximum), 50% inspiratory time Manual (15 sec maximum) 21-100 Yes (controlled cycle, started by operator) 0-50 0-80 Yes (6 L/min, synchronized at inspiratory phase) INTERMED INTER 7 PLUS Worldwide No Yes Adult, pediatric, neonatal 10-2,000 2-120 (controlled), 0-180 (demand) 5-80 0-180 0.1-15 0.1 minimum (indirectly adjustable) 1:99 to 9.9:1 (indirectly adjustable) Manual (15 sec maximum), automatic (0-2 sec) Manual (15 sec maximum) 21-100 Yes (controlled cycle, started by operator) 0-50 0-80 Yes (3 or 6 L/min, synchronized at inspiratory phase or continuous) with FiO2 and volume compensation Pressure, flow 2 25-100% for PSV and PCV Yes (% of tidal volume, sigh ratio or % of Pcontr, sigh ratio) Yes Inspiratory sensitivity by pressure (0.5-10 cm H2O), inspiratory sensitivity by flow (0.2-15 L/min), TGI (3 or 6 L/min synchronized at expiratory phase), apnea interval (3-60 sec), backup rate, endotracheal tube compensation, slow PV curve maneuver INTERMED INTER PLUS VAPS/GMX Worldwide No Yes Adult, pediatric, neonatal 10-2,000 2-120 (controlled), 0-150 (demand) 5-80 0-180 0.1-15 0.1 minimum (indirectly adjustable) 1:99 to 9.9:1 (indirectly adjustable) Manual (15 sec maximum), 50% inspiratory time Manual (15 sec maximum) 21-100 Yes (controlled cycle, started by operator) 0-50 0-80 Yes (6 L/min, synchronized at inspiratory phase)

Trigger mechanism Bias/base flow range, L/min Pressure slope/ramp adjustment Sigh 100% O2 Others

Pressure NA Yes/yes No Not specified None specified

Pressure, flow 2 Automatic Yes (1.5 x tidal volume, each 100 cycles or 7 min) No Inspiratory sensitivity by pressure (0.5-10 cm H2O), inspiratory sensitivity by flow (0.2-15 L/min), TGI (6 L/min synchronized at expiratory phase), apnea interval (4-30 sec)

Pressure, flow 2 Automatic Yes (1.5 x tidal volume, each 100 cycles or 7 min) No Inspiratory sensitivity by pressure (0.5-10 cm H2O), inspiratory sensitivity by flow (0.2-15 L/min), TGI (6 L/min synchronized at expiratory phase), apnea interval (4-30 sec)

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

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53

Ventilators, Intensive Care Product Comparison Chart

MODEL OPERATING MODES Assist/control Volume breaths Pressure breaths SIMV Volume breaths SIMV Pressure breaths Pressure support Spontaneous/CPAP Pressure support Apnea-backup vent Combination modes Active/responsive valve Bilevel/APRV Others IMPACT Uni-Vent EMV+ INTERMED INTER 5 PLUS/GMX INTERMED INTER 7 PLUS INTERMED INTER PLUS VAPS/GMX

Yes Yes Yes Yes Yes Yes Yes Yes No No No None specified

Yes Yes Yes Yes Yes Yes Yes VAPS Yes Yes Constant and decelerating wave flow, time cycle (A/C, SIMV), VAPS (A/C, SIMV)

Yes Yes Yes Yes Yes Yes Yes VAPSC/V Yes Yes Constant and decelerating sinusoidal wave flow, time cycle (A/C, SIMV, PSV), VAPSC/V (A/C, SIMV), pressure controlled with maximum volume limited and minimum volume guaranteed

Yes Yes Yes Yes Yes Yes Yes VAPS Yes Yes Constant and decelerating wave flow, time cycle (A/C, SIMV), VAPS (A/C, SIMV)

MONITORED PARAMETERS Pressure PIP MAP PEEP Volume Tidal Minute Spontaneous minute FiO2 Respiratory rate Inspiratory time Expiratory time IE Others

Yes Yes Yes Yes Yes Yes Yes Yes Yes No Yes None specified

Yes Yes Yes Yes Yes Not specified Yes Yes Yes No Yes Tidal volume (inspiratory and expiratory), plateau pressure, peak flow (inspiratory and expiratory), patient resistance (inspiratory and expiratory), patient compliance (static and dynamic), weaning index (RSBI), negative inspiratory pressure, WOB, graphics (PxT, FxT, VxT, PxV, FxV), trends (PIP, PEEP, rate, tidal volume, resistance, compliance)

Yes Yes Yes Yes Yes Yes Yes Yes Yes No Yes Tidal volume (inspiratory and expiratory), plateau pressure, patient resistance (inspiratory and expiratory), patient compliance (static and dynamic), weaning index (RSBI), WOB, graphics (PxT, FxT, VxT, PxV, FxV), trends (PIP, PEEP, rate, tidal volume, resistance, compliance), autoPEEP, occlusion pressure PO.1

Yes Yes Yes Yes Yes Not specified Yes Yes Yes No Yes Tidal volume (inspiratory and expiratory), plateau pressure, peak flow (inspiratory and expiratory), patient resistance (inspiratory and expiratory), patient compliance (static and dynamic), weaning index (RSBI), negative inspiratory pressure, WOB, graphics (PxT, FxT, VxT, PxV, FxV), trends (PIP, PEEP, rate, tidal volume, resistance, compliance)

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Ventilators, Intensive Care Product Comparison Chart

MODEL PATIENT ALARMS FiO2 Low minute volume Low inspiratory pressure High pressure Loss of PEEP Apnea High continuous pressure/occlusion Inverse IE High respiratory rate High minute volume High PEEP Breathing circuit disconnect Others IMPACT Uni-Vent EMV+ Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes SpO2, heart rate INTERMED INTER 5 PLUS/GMX Yes Yes Yes Yes Yes Yes Yes No No No Yes Yes None specified INTERMED INTER 7 PLUS Yes Yes Yes Yes Yes Yes Yes No Yes Yes Yes Yes Low exhaled tidal volume, high inspiratory tidal volume, low rate, high CPAP, autoPEEP, auto cycle Yes Yes Yes Yes Yes Patient disconnect, patient circuit leak, circuit occlusion (inspiration and expiration), flow sensor disconnected, battery failure, fan failure, exhalation valve failure RS232, RS485, USB, LAN Yes Not specified Not specified Not specified Not specified Yes INTERMED INTER PLUS VAPS/GMX Yes Yes Yes Yes Yes Yes Yes No No No Yes Yes None specified

EQUIPMENT ALARMS Gas supply failure Power failure Vent inoperative Low battery Self-diagnostics Others

Yes Yes Yes Yes Yes None specified

Yes Yes Yes Yes Not specified None specified

Yes Yes Yes Yes Not specified None specified

INTERFACING Output ports Remote alarm/display Analog output Report generation Display Hard copy Archival disk Network

USB Compatible No No No No No

RS232 No Not specified Not specified Not specified Not specified Not specified

RS232 No Not specified Not specified Not specified Not specified Not specified

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

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Ventilators, Intensive Care Product Comparison Chart

MODEL DISPLAY TYPES DATA DISPLAYED MRI COMPATIBILITY SUITABLE FOR AIRCRAFT USE Approved by PNEUMATIC POWER Compressor Compressed gases Pressure ranges Turbine/piston LINE POWER, VAC Current, amps Watts INTERNAL BATTERY Type (number) Operating time, hr Rechargeable Recharging time, hr EXTERNAL BATTERY Type (number) Operating time, hr Rechargeable Recharging time, hr H x W x D, cm (in) WEIGHT, kg (lb) IMPACT Uni-Vent EMV+ LED, LCD Numbers, graphics, alarms With extended circuit Yes Not specified Yes O2 40-80 psi Not specified 95-265 autosensing 3 40 Yes Li-ion (not specified) 10 Yes 4 Not specified Not specified Not specified Not specified Not specified 32 x 19 x11 (12.5 x 7.5 x 4.5) 4.1 (9) INTERMED INTER 5 PLUS/GMX 7-segment numeric, LCD, 320 x 240 pixels, mono or color Numbers, text, graphics, loops, trends Not specified Not specified Not specified Optional INTER 3500 O2, air 2.5-5 kg/cm² No 100-240 0.50-0.22 50 Yes Lead-acid 12 V/2.2 A-h (1) 2 Yes 8 Yes 12-14 V, 2.0 A (not specified) Not specified Not specified Not specified 16 x 29 x 31.5 (6.3 x 11.4 x 12.4) 16 (35.3) INTERMED INTER 7 PLUS 30.5 cm (12"), 1024 x 760 XGA resolution color touchscreen Numbers, text, graphics, loops, trends Not specified Not specified Not specified Optional INTER 3500 O2, air 2.5-6 kg/cm² No 100-240 0.50-0.22 50 Yes Lead-acid 12 V/2.2 A-h (1) 3 Yes 8 Yes 12-14 V, 2.0 A (not specified) Not specified Not specified Not specified 30 x 29 x 40 (11.8 x 11.4 x 15.7) 12 (26.5) INTERMED INTER PLUS VAPS/GMX 7-segment numeric, LCD, 320 x 240 pixels, mono or color Numbers, text, graphics, loops, trends Not specified Not specified Not specified Optional INTER 3500 O2, air 2.5-5 kg/cm² No 100-240 0.50-0.22 50 Yes Lead-acid 12 V/2.2 A-h (1) 2 Yes 8 Yes 12-14 V, 2.0 A (not specified) Not specified Not specified Not specified 16 x 29 x 31.5 (6.3 x 11.4 x 12.4) 16 (35.3)

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Ventilators, Intensive Care Product Comparison Chart

MODEL PURCHASE INFORMATION List price Warranty Service Factory/on-site Training 3rd-party service Parts availability Delivery time, ARO Year first sold Number sold USA/worldwide Fiscal year OTHER SPECIFICATIONS IMPACT Uni-Vent EMV+ INTERMED INTER 5 PLUS/GMX INTERMED INTER 7 PLUS INTERMED INTER PLUS VAPS/GMX

Not specified 1 year Yes/per contract Yes No Yes Stock to 30 days 2008 Not specified Not specified January to December Includes built-in air/O2 mixer and compressor; altitude and PEEP compensation; automatic backlighting of LCD; built-in pulse oximeter; internal backup ventilator. 17429 October 2008

Not specified 2 years Yes/yes Yes Yes Yes 30 days 2003 Not specified Not specified Complies with IEC 60601-1, IEC 60601-1-2, IEC 606012-12, and EN 794-1.

Not specified 2 years Yes/yes Yes Yes Yes 30 days 2007 Not specified Not specified Complies with IEC 60601-1, IEC 60601-1-2, IEC 606012-12, and EN 794-1.

Not specified 2 years Yes/yes Yes Yes Yes 30 days 2002 Not specified Not specified Complies with IEC 60601-1, IEC 60601-1-2, IEC 606012-12, and EN 794-1.

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

17429 October 2008

17429 October 2008

17429 October 2008

©2008 ECRI Institute. All Rights Reserved

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Ventilators, Intensive Care Product Comparison Chart

MODEL MAQUET Servo-i (Adult : Infant : Universal Basic : Universal Extended) Worldwide Yes Yes Adult, pediatric, neonatal 100-4,000 : 2-350 : 2-4,000 : 2-4,000 0-200 0-120 0-150 0.1-5 0-0.4 : 0-0.2 1:10 to 4:1 0-30% respiratory cycle Yes 21-100 Yes 0-50 0-100 Optional Pressure, flow, neural 0.5-2 Yes/yes No Yes Inspiratory cycle off MAQUET Servo-s (Adult : Pediatric) NEWPORT E100M NEWPORT e360

WHERE MARKETED FDA CLEARANCE CE MARK (MDD) PATIENT TYPE CONTROLS Tidal volume, mL Inspiratory flow, L/min Inspiratory pressure, cm H2O Respiratory rate, bpm Inspiratory time, sec Expiratory time, sec IE ratio Inspiratory hold/plateau Expiratory hold FiO2, % Manual breath PEEP/CPAP, cm H2O Pressure support, cm H2O Nebulizer Trigger mechanism Bias/base flow range, L/min Pressure slope/ramp adjustment Sigh 100% O2 Others

Worldwide Yes Yes Adult, pediatric 100-2,000 0-200 0-120 0-160 0.1-5 0-0.4 : 0-0.2 1:10 to 4:1 0-30% respiratory cycle Yes 21-100 Yes 0-50 0-100 Optional Pressure, flow 0.5-2 Yes/yes No Yes Inspiratory cycle off

Worldwide Yes Yes Adult to neonatal 5-5,000 1-100 0-120 1-120 0.1-3 Determined by rate and inspiratory time 1:99 to 4:1 Using pressure limit Not specified 21-100 Yes 0-25+ Time-limited demand flow Yes Pressure/autocontrol 0-20+ Yes, manual No NA None specified

Worldwide Yes Yes Adult, pediatric, infant 20-3,000 (5-3,000 in certain markets) 1-180 0-120 VCV, 0-80 PCV 1-120 (1-150 in certain markets) 0.1-5 Determined by rate and inspiratory time 1:99 to 4:1, depends on rate and inspiratory time Manual inspiratory hold for up to 15 sec, automatic pause, off, 0.1-2 sec 20 sec maximum 21-100 Yes 0-45 0-60 Optional Pressure or flow, automatically compensated for bias flow Auto compensation up to 25 (up to 40 with NIV on) Automatic (some markets) and manual slope rise adjustment Yes Yes Automatic (some markets) and manual expiratory threshold adjustment (FlexCycle), open exhalation valve (biphasic pressure release ventilation), NIV, flow wave, sigh, pause, compliance compensation

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Ventilators, Intensive Care Product Comparison Chart

MODEL MAQUET Servo-i (Adult : Infant : Universal Basic : Universal Extended) MAQUET Servo-s (Adult : Pediatric) NEWPORT E100M NEWPORT e360

OPERATING MODES Assist/control Volume breaths Pressure breaths SIMV Volume breaths SIMV Pressure breaths Pressure support Spontaneous/CPAP Pressure support Apnea-backup vent Combination modes Active/responsive valve Bilevel/APRV Others

Yes Yes Yes Yes Yes Yes Yes PRVC Yes Bivent NIV, nasal CPAP, auto mode, NAVA1

Yes Yes Yes Yes Yes Yes Yes PRVC Yes Bivent NIV

Yes Yes Yes Yes Time-limited demand flow Yes Yes Not specified Open valve during pressure ventilation Valve is open during pressure ventilation Automatic trigger control

Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Volume target pressure control and pressure support, NIV with any breath type/mode

MONITORED PARAMETERS Pressure PIP MAP PEEP Volume Tidal Minute Spontaneous minute FiO2 Respiratory rate Inspiratory time Expiratory time IE Others

Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Open-lung tool, 24 hr trends, systems event alarm, capnography option, proximal airway sensor

Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Pressure and flow volume waveforms, trended data, lung mechanics

Yes Yes Yes Set No No Set Yes Set No Display None specified

Yes Yes Yes Yes Yes Yes Yes Yes Yes No Yes RSBI, peak inspiratory flow, peak expiratory flow, time constant, inspiratory and expiratory resistance, dynamic effective and static compliance, inspiratory volumes, autoPEEP, VTE % variance, waves, loops, trends

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

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Ventilators, Intensive Care Product Comparison Chart

MODEL MAQUET Servo-i (Adult : Infant : Universal Basic : Universal Extended) Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Technical systems, patientflow overage, leakage Yes Yes Yes Yes Yes System continuous, pre-use MAQUET Servo-s (Adult : Pediatric) NEWPORT E100M NEWPORT e360

PATIENT ALARMS FiO2 Low minute volume Low inspiratory pressure High pressure Loss of PEEP Apnea High continuous pressure/occlusion Inverse IE High respiratory rate High minute volume High PEEP Breathing circuit disconnect Others EQUIPMENT ALARMS Gas supply failure Power failure Vent inoperative Low battery Self-diagnostics Others INTERFACING Output ports Remote alarm/display Analog output Report generation Display Hard copy Archival disk Network

Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Technical systems, patientflow overage, leakage Yes Yes Yes Yes Yes System continuous, pre-use

Optional Optional Yes Yes Yes Yes Yes Yes NA NA Yes Not specified None specified Yes Yes Yes Yes Yes Remote alarm output, external alarm, silence cable, autoset alarms RS232, external alarm silence Yes Yes No No No No

Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes None specified Yes Yes Yes Yes Yes Remote alarm output, external alarm silence cable, flow sensor error RS232, VGA, USB (save and download), remote alarm Yes Yes Yes Yes Yes Yes

RS232C, nurse call Yes Yes Optional Optional Optional Yes

RS232C, nurse call Yes Yes Optional Optional No Yes

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Ventilators, Intensive Care Product Comparison Chart

MODEL MAQUET Servo-i (Adult : Infant : Universal Basic : Universal Extended) Flat touchscreen All monitored parameters Approved for MRI conditional Yes Not specified Optional O2, air 29-94 psi NA 100-120, 220-240; 50/60 Hz 5 40 Yes Ni-MH (1-6 units) 0.5-3 Yes 3 (full discharge) Optional Optional Optional Optional Optional 41.5 x 30 x 20.5 (16.3 x 11.8 x 8.1) for patient unit 15 (33) for patient unit MAQUET Servo-s (Adult : Pediatric) NEWPORT E100M NEWPORT e360

DISPLAY TYPES DATA DISPLAYED MRI COMPATIBILITY SUITABLE FOR AIRCRAFT USE Approved by PNEUMATIC POWER Compressor Compressed gases Pressure ranges Turbine/piston LINE POWER, VAC Current, amps Watts INTERNAL BATTERY Type (number) Operating time, hr Rechargeable Recharging time, hr EXTERNAL BATTERY Type (number) Operating time, hr Rechargeable Recharging time, hr H x W x D, cm (in) WEIGHT, kg (lb)

Flat touchscreen All monitored parameters No No NA Optional O2, air 29-94 psi NA 100-120, 220-240; 50/60 Hz 5 40 Yes 12 V (not specified) 1 Yes 6 (full discharge) Optional Optional Optional Optional Optional 52 x 38 x 30 (20.5 x 15 x 11.8) 18 (39.7)

LED, LCD Numbers No Not specified Not specified Optional O2, air 35-90 psi No 100/120/220/240 0.07-0.14 Not specified Yes Sealed lead-acid (1) 6-8 Yes Not specified Not specified Not specified Not specified Not specified Not specified 26.7 x 24.1 x 16.5 (10.5 x 9.5 x 6.5) 8.2 (18)

LED, LCD Numbers, graphic waveforms and loops, mechanics calculations No Not specified Not specified Optional O2 (no air required if FiO2 @ 100%), air (no O2 required if FiO2 @ 21%) 35-90 psi No 100/120/220/240 0.5-1 Not specified Yes Sealed lead-acid (1) 1 Yes Not specified Yes Not specified Not specified Not specified Not specified 30.7 x 35.3 x 35.3 (12.1 x 13.9 x 13.9) 17.3 (38)

This is the fourth of five pages covering the above model(s). These specifications continue onto the next page.

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Ventilators, Intensive Care Product Comparison Chart

MODEL MAQUET Servo-i (Adult : Infant : Universal Basic : Universal Extended) MAQUET Servo-s (Adult : Pediatric) NEWPORT E100M NEWPORT e360

PURCHASE INFORMATION List price Warranty Service Factory/on-site Training 3rd-party service Parts availability Delivery time, ARO Year first sold Number sold USA/worldwide Fiscal year OTHER SPECIFICATIONS

Not specified 1 year Yes/yes Yes Yes (under contract) Yes 45 days 2001 Not specified January to December Transport capability; can be used for treatment with Heliox (80-20, 79-21, 78-22 mixtures can be used) both invasively and noninvasilvely and in any mode of ventilation offered; optional proximal airway sensor. Meets requirements of IEC 606011 and ISO 10651-1. 17429 October 2008

1NAVA

Not specified 1 year Yes/yes Yes Yes (under contract) Yes 45 days 2004 Not specified January to December Transport capability. Meets requirements of IEC 606011-2.

Not specified 3 years/12,000 hr Yes/yes Yes Yes Yes 30-60 days 1997 Not specified January to December Automatic trigger control and alarm settings; timelimited demand flow allows delivery of mandatory flow to assist spontaneous patient breaths.

Not specified 2 years Yes/yes Yes Yes Yes 30-60 days 2006 Not specified January to December Optional 38.1 cm (15") monitor.

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

17429 October 2008

17429 October 2008

17429 October 2008

stands for Neurally Adjusted Ventilatory Assist.

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Ventilators, Intensive Care Product Comparison Chart

MODEL WHERE MARKETED FDA CLEARANCE CE MARK (MDD) PATIENT TYPE CONTROLS Tidal volume, mL Inspiratory flow, L/min Inspiratory pressure, cm H2O Respiratory rate, bpm Inspiratory time, sec Expiratory time, sec IE ratio Inspiratory hold/plateau Expiratory hold FiO2, % Manual breath PEEP/CPAP, cm H2O Pressure support, cm H2O Nebulizer Trigger mechanism NEWPORT e500 Wave Worldwide Yes Yes Adult, pediatric, infant 20-3,000 1-180 0-120 VCV, 0-80 PCV 1-120 0.1-5 Determined by rate and inspiratory time 1:99 to 4:1, depends on rate and inspiratory time Manual inspiratory hold for up to 15 sec, automatic pause, off; 0.5, 1, or 2 sec 20 sec maximum 21-100 Yes 0-45 0-60 Optional Pressure or flow, automatically compensated for bias flow RESPIRONICS Esprit Worldwide Yes Yes Adult, pediatric, neonatal 50-2,500 3-140 (compliance compensated, actual to 200) 0-100 1-80 (adult, pediatric), 1-150 (neonatal) 0.1-9.9 (0.1 resolution) 0.15-59.9 1:599 to 4:1 0-2 sec (0.1 sec resolution) Yes 21-100 Yes 0-35 0-100 (relative to PEEP) Optional Pressure -20 to -0.1 cm H2O (adult, pediatric), flow 0.5-20 L/min (adult, pediatric), 3.3-10 L/min (neonatal), 0.1 L/min resolution, Auto-Trak auto adjusts trigger sensitivity based on patient demand by monitoring a combination of 6 variables simultaneously (flow, pressure, volume, effort) up to a leak rate of 60 L/min 3.5-23 (adult, pediatric), 3.310.3 (neonatal) 0.1-0.9 sec (adult, pediatric), 0.1-0.5 (neonatal) No Yes (120 sec duration) None specified SAIME/RESMED ELISEE 250 : ELISEE 350 Europe No Yes Adult, pediatric 300-2,500 adult, 50-500 pediatric 5-180 5-60 adult, 3-40 pediatric 2-50 adult, 2-80 pediatric 0.3-3 0.25-9 1:0.4 to 1:9.9 0-2 adult, 0-1.5 pediatric 0-12 sec 21-100 Yes 0-25 adult, 0-20 pediatric 5-60 adult, 3-40 NIV, 3-60 invasive, pediatric Yes Pressure, flow SIARE Siaretron 1000 ICU Worldwide, except USA No Yes Adult, pediatric, neonatal 5-3,000 0-120 0-80 1-150 0.07-5 0.07-5 1:4 to 3:1 0-50% Yes 21-100 Not specified 0-20, 0-50 level 1, 0-25 level 2 Yes Yes Pressure, optional flow

Bias/base flow range, L/min Pressure slope/ramp adjustment Sigh 100% O2 Others

Auto compensation up to 25 (up to 40 with NIV on) Automatic (some markets) and manual slope rise adjustment Yes Yes Automatic (some markets) and manual expiratory threshold adjustment (FlexCycle), open exhalation valve (biphasic pressure release ventilation), NIV, flow wave, sigh, pause, compliance compensation

Auto to 30 Yes/yes Yes Yes None specified

1-15 optional Yes/yes Yes Yes None specified

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

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Ventilators, Intensive Care Product Comparison Chart

MODEL OPERATING MODES Assist/control Volume breaths Pressure breaths SIMV Volume breaths SIMV Pressure breaths Pressure support Spontaneous/CPAP Pressure support Apnea-backup vent Combination modes Active/responsive valve Bilevel/APRV Others NEWPORT e500 Wave RESPIRONICS Esprit SAIME/RESMED ELISEE 250 : ELISEE 350 SIARE Siaretron 1000 ICU

Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Volume target pressure control and pressure support, NIV with any breath type/mode

Yes Yes Yes Yes Yes Yes Yes Yes Neonatal mode Not specified NPPV spontaneous/timed, FlowTrak (VCV) Speaking Mode allows for speech in VCV, PCV, and PSV modes automatically changing monitored values from expiratory to inspiratory and adding additional alarms for occlusions and disconnects, if an occlusion occurs the Esprit automatically switches back to standard ventilation and alarms audible and visually

Yes Yes Yes Yes Yes Yes Yes Not specified Not specified Not specified Pressure support, 5 preset modes

Yes Yes Yes No Yes Yes Yes Not specified Not specified Yes NIV

MONITORED PARAMETERS Pressure PIP MAP PEEP Volume Tidal Minute Spontaneous minute FiO2 Respiratory rate Inspiratory time Expiratory time IE Others

Yes Yes Yes Yes Yes Yes Yes (with autocalibration that does not affect FiO2 delivery) Yes Yes No Yes F/VT, WOBim, peak inspiratory flow, peak expiratory flow, TEmin, inspiratory and expiratory resistance, dynamic effective and static compliance, inspiratory volumes, autoPEEP, VTE % variance, waves, loops, trends

Yes Yes Yes Yes Yes Yes Yes Yes No No Yes % leak, spontaneous and total minute volume, spontaneous rate, measured end-expiratory pressure, RSBI, Ti/Ttot, 40 parameters are trended simultaneously for 72 hr and displayed 3 at a time

Yes Yes Yes Yes Yes Yes Yes Apnea, leaks Yes Yes Yes Events log

Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes None specified

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Ventilators, Intensive Care Product Comparison Chart

MODEL PATIENT ALARMS FiO2 Low minute volume Low inspiratory pressure High pressure Loss of PEEP Apnea High continuous pressure/occlusion Inverse IE High respiratory rate High minute volume High PEEP Breathing circuit disconnect Others EQUIPMENT ALARMS Gas supply failure Power failure Vent inoperative Low battery Self-diagnostics Others INTERFACING Output ports Remote alarm/display Analog output Report generation Display Hard copy Archival disk Network NEWPORT e500 Wave Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes None specified Yes Yes Yes Yes Yes Remote alarm output, external alarm silence cable RS232, printer, external alarm silence Yes Yes Yes Yes No Yes RESPIRONICS Esprit High and low 0-60 L/min 3-105 cm H2O 10-105 cm H2O 0-35 cm H2O 10-60 sec Yes Yes 0-150 bpm 0-60 L/min (adult, pediatric), 0-5 L/min (neonatal) Yes Not specified None specified Yes Yes Yes Yes EST, SST 120 sec alarm silence, reset RS232 Yes (nurse call) Yes Optional Yes No Interfaces with patient monitoring companies (Philips, GE, HBOC McKesson, Spacelabs, MediServe, Pro-Touch; several others in various stages of development) SAIME/RESMED ELISEE 250 : ELISEE 350 Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Not specified None specified Yes Yes Yes Yes Yes Exhale valve, low battery, temperature RS232 Yes No 38.1 cm (15") No No RS232 SIARE Siaretron 1000 ICU Yes Yes Yes Yes No Yes Yes No Yes Yes Yes Yes None specified Yes Yes Yes Yes Sensor failure, wrong gas connection Valve failure RS232 No No Yes No No SIARELINK

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

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Ventilators, Intensive Care Product Comparison Chart

MODEL DISPLAY TYPES DATA DISPLAYED NEWPORT e500 Wave LED, LCD, vacuum fluorescent Numbers, graphic waveforms and loops, mechanics calculations No Not specified Not specified Optional O2 (no air required if FiO2 @ 100%), air (no O2 required if FiO2 @ 21%) 35-90 psi No 100/120/220/240 0.07-0.14 Not specified Yes Sealed lead-acid (1) 0.5 (1.5 without GDM) Yes Not specified Yes Not specified Not specified Not specified Not specified Varies; 3 modular components 18.7 (41.3 ), 2.9 (6.4), 3.4 (7.5); 3 modular components RESPIRONICS Esprit 26.4 cm (10.4") color touchscreen Numbers, waveform, loops, respiratory mechanics, trended data, NICO interfaced data Not specified Not specified Not specified Not needed O2 (50 psi), air (blower) 40-90 psi Blower 100-240 6 maximum 30 Yes Lead-acid (not specified) 30 Yes ~10 Yes Lead-acid (not specified) 4, requires use of backup battery Yes ~15 40 x 36 x 61 (16 x 14 x 24) 30 (66.2) SAIME/RESMED ELISEE 250 : ELISEE 350 EL touchscreen Numbers, waveforms, loops, trends Not specified Not specified Not specified Internal microblower External compressed gas 3-7 bar, 45-90 psi Not specified 110-230, 50/60 Hz 1-0.6 75 maximum Yes Lithium ion (not specified) 3 5 5 Yes Lithium ion (not specified) 3 5 5 29 x 25 x 13 (11.4 x 9.8 x 5.1) 4.1 (9) SIARE Siaretron 1000 ICU LED, LCD Numbers

MRI COMPATIBILITY SUITABLE FOR AIRCRAFT USE Approved by PNEUMATIC POWER Compressor Compressed gases Pressure ranges Turbine/piston LINE POWER, VAC Current, amps Watts INTERNAL BATTERY Type (number) Operating time, hr Rechargeable Recharging time, hr EXTERNAL BATTERY Type (number) Operating time, hr Rechargeable Recharging time, hr H x W x D, cm (in) WEIGHT, kg (lb)

Not specified Not specified Not specified Optional O2, air 3.5 ±0.75 bar No 100-240, 12 VDC 0.15 30 Yes Lead-acid (1) 2 Yes Not specified Yes Lead-acid (1) 10 Yes Not specified 16 x 36 x 35 (6.2 x 14.2 x 13.8) 4.9 (10.8)

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Ventilators, Intensive Care Product Comparison Chart

MODEL PURCHASE INFORMATION List price Warranty Service Factory/on-site Training 3rd-party service Parts availability Delivery time, ARO Year first sold Number sold USA/worldwide Fiscal year OTHER SPECIFICATIONS NEWPORT e500 Wave RESPIRONICS Esprit SAIME/RESMED ELISEE 250 : ELISEE 350 SIARE Siaretron 1000 ICU

Not specified 1 year Yes/yes Yes Yes Yes 30-60 days 2001 Not specified January to December None specified.

Not specified 2 years Yes/yes Yes, user configured Yes Yes 1-2 weeks 1999 Not specified January to December Meets requirements of CEI Class 1 Type B, EN 1281-1, IEC 60601-1, IEC 60601-11, IEC 60601-1-2, IEC 60601-2-12, and ISO 5356. CSA mark shown. 17429 October 2008

Not specified 2 years Yes/yes Yes No Yes Not specified 2004 Not specified July to June None specified.

Not specified 2 years Not specified Not specified Not specified Not specified Not specified Not specified Not specified January to December Meets requirements of CEI Class 1 Type B, EN 1281-1, IEC 60601-1, IEC 60601-11, IEC 60601-1-2, IEC 60601-2-12, and ISO 5356. 17429 October 2008

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

17429 October 2008

17429 October 2008

©2008 ECRI Institute. All Rights Reserved

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Ventilators, Intensive Care Product Comparison Chart

MODEL WHERE MARKETED FDA CLEARANCE CE MARK (MDD) PATIENT TYPE CONTROLS Tidal volume, mL Inspiratory flow, L/min Inspiratory pressure, cm H2O Respiratory rate, bpm Inspiratory time, sec Expiratory time, sec IE ratio Inspiratory hold/plateau Expiratory hold FiO2, % Manual breath PEEP/CPAP, cm H2O Pressure support, cm H2O Nebulizer Trigger mechanism Bias/base flow range, L/min Pressure slope/ramp adjustment Sigh 100% O2 Others SIARE Siaretron 1000 IPER Worldwide, except USA No Yes Adult, pediatric, neonatal 5-3,000 0-120 0-80 1-150 0.15-5 0.15-5 1:4 to 3:1 0-50% Yes 21-100 Not specified 0-20, 0-50 level 1, 0-25 level 2 Yes Yes Pressure, optional flow 1-15 optional Yes/yes Yes Yes None specified SIARE Siaretron 3000 ICU Worldwide, except USA No Yes Adult, pediatric, neonatal 5-3,000 0-120 0-80 1-150 0.07-5 0.07-5 1:4 to 3:1 0-50% Yes 21-100 Not specified 0-20, 0-50 level 1, 0-25 level 2 Yes Yes Pressure, optional flow 1-15 optional Yes/yes Yes Yes None specified SIARE Siaretron 4000 ICU Worldwide, except USA No Yes Adult, pediatric, neonatal 5-3,000 0-120 0-80 1-150 0.07-5 0.07-5 1:4 to 4:1 0-50% Yes 21-100 Not specified 0-20, 0-50 level 1, 0-25 level 2 Yes Yes Pressure, flow 1-15 optional Yes/yes Yes Yes None specified TAEMA eXtend Worldwide, except USA No Yes Adult to infant 20-2,000; 5,000 1-200 0-90 1-80 0.2-5 20-90% cycle time 1:4 to 4:1 0-60% cycle time Yes 21-100 No 0-40 0-40 Yes Pressure, flow 0-30, automatic 50-150 Yes No None specified

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Ventilators, Intensive Care Product Comparison Chart

MODEL OPERATING MODES Assist/control Volume breaths Pressure breaths SIMV Volume breaths SIMV Pressure breaths Pressure support Spontaneous/CPAP Pressure support Apnea-backup vent Combination modes Active/responsive valve Bilevel/APRV Others SIARE Siaretron 1000 IPER SIARE Siaretron 3000 ICU SIARE Siaretron 4000 ICU TAEMA eXtend

Yes Yes Yes No Yes Yes Yes Not specified Not specified Yes NIV

Yes Yes Yes No Yes Yes Yes Not specified Not specified Yes NIV

Yes Yes Yes No Yes Yes Yes Yes Not specified Yes NIV

Yes Yes Yes Yes Yes Yes Yes Not specified Not specified Not specified PS-PEEP with minivent rate, inverse I:E, VAPS, PRVC, APRV, noninvasive, MRV

MONITORED PARAMETERS Pressure PIP MAP PEEP Volume Tidal Minute Spontaneous minute FiO2 Respiratory rate Inspiratory time Expiratory time IE Others

Yes Yes Yes No No No No Yes Yes Yes Yes None specified

Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes None specified

Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes None specified

Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes f/Vt, PV curve with low inflation flow method, leaks index, Pplat, VTi, VTe

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

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Ventilators, Intensive Care Product Comparison Chart

MODEL PATIENT ALARMS FiO2 Low minute volume Low inspiratory pressure High pressure Loss of PEEP Apnea High continuous pressure/occlusion Inverse IE High respiratory rate High minute volume High PEEP Breathing circuit disconnect Others EQUIPMENT ALARMS Gas supply failure Power failure Vent inoperative Low battery Self-diagnostics Others INTERFACING Output ports Remote alarm/display Analog output Report generation Display Hard copy Archival disk Network SIARE Siaretron 1000 IPER No No Yes Yes No Yes Yes No No No Yes Yes None specified Yes Yes Yes Yes Sensor failure, wrong gas connection Valve failure RS232 No No Yes No No SIARELINK SIARE Siaretron 3000 ICU Yes Yes Yes Yes No Yes Yes No Yes Yes Yes Yes None specified Yes Yes Yes Yes Sensor failure, wrong gas connection Valve failure RS232 No No Yes No No SIARELINK SIARE Siaretron 4000 ICU Yes Yes Yes Yes Yes Yes Yes No Yes Yes Yes Yes None specified Yes Yes Yes Yes Sensor failure, wrong gas connection Valve failure RS232 No No Yes No No SIARELINK TAEMA eXtend Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Gas disconnect, battery alarms Yes Yes Yes Yes (optional for UPS) Yes Messages, alarms, history RS232 (2) Yes No Yes No No Vital signs monitor

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Ventilators, Intensive Care Product Comparison Chart

MODEL DISPLAY TYPES DATA DISPLAYED MRI COMPATIBILITY SUITABLE FOR AIRCRAFT USE Approved by PNEUMATIC POWER Compressor Compressed gases Pressure ranges Turbine/piston LINE POWER, VAC Current, amps Watts INTERNAL BATTERY Type (number) Operating time, hr Rechargeable Recharging time, hr EXTERNAL BATTERY Type (number) Operating time, hr Rechargeable Recharging time, hr H x W x D, cm (in) WEIGHT, kg (lb) SIARE Siaretron 1000 IPER LED, LCD Numbers Not specified Not specified Not specified No O2, air 3.5 ±0.75 bar No 12 VDC 1.2 15 Yes Ni-Cd (2) 6 Yes Not specified No NA NA NA NA 16 x 36 x 35 (6.2 x 14.2 x 13.8) 4.9 (10.8) SIARE Siaretron 3000 ICU 12.7 cm (5") graphic display, LED, LCD Numbers, waveforms, loops, respiratory mechanics Not specified Not specified Not specified Optional O2, air 3.5 ±0.75 bar No 100-240, 12 VDC 0.15 30 Yes Lead-acid (1) 2 Yes Not specified Yes Lead-acid (1) 10 Yes Not specified 32 x 36 x 35 (12.5 x 14.2 x 13.8) 5.2 (11.5) SIARE Siaretron 4000 ICU 38.1 cm (15") graphic color display, TFT Numbers, waveforms, loops, respiratory mechanics Not specified Not specified Not specified Optional O2, air 3.5 ±0.75 bar No 100-240, 12 VDC 0.30 60 Yes Lead-acid (1) 2 Yes Not specified Yes Lead-acid (1) 10 Yes Not specified 35 x 41 x 31 (13.8 x 16 x 12) 10 (22) TAEMA eXtend 15" color touchscreen Numbers, graphics, waveforms, trends, PV curve Not specified Not specified Not specified Optional O2, air 2.8-6 bar No 10-240, 50/60 Hz Not specified 90 VA Yes Sealed lead-acid (not specified) 0.5 Yes 8 Optional Any (not specified) Not specified Not specified Not specified 50 x 45 x 28 (19.7 x 17.7 x 11) 27 (59.5)

This is the fourth of five pages covering the above model(s). These specifications continue onto the next page.

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Ventilators, Intensive Care Product Comparison Chart

MODEL PURCHASE INFORMATION List price Warranty Service Factory/on-site Training 3rd-party service Parts availability Delivery time, ARO Year first sold Number sold USA/worldwide Fiscal year OTHER SPECIFICATIONS SIARE Siaretron 1000 IPER SIARE Siaretron 3000 ICU SIARE Siaretron 4000 ICU TAEMA eXtend

Not specified 2 years Not specified Not specified Not specified Not specified Not specified Not specified Not specified January to December For use in hyperbaric chamber; autocompensated up to 60 mL H2O. Meets requirements of CEI Class 1 Type B, IEC 60601-1, IEC 60601-1-2, IEC 60601-2-12, and ISO 5369. 17429 October 2008

Not specified 2 years Not specified Not specified Not specified Not specified Not specified Not specified Not specified January to December Meets requirements of CEI Class 1 Type B, EN 1281-1, IEC 60601-1, IEC 60601-11, IEC 60601-1-2, IEC 60601-2-12, and ISO 5356. 17429 October 2008

Not specified 2 years Not specified Not specified Not specified Not specified Not specified Not specified Not specified January to December Meets requirements of CEI Class 1 Type B, EN 1281-1, IEC 60601-1, IEC 60601-11, IEC 60601-1-2, IEC 60601-2-12, and ISO 5356. 17429 October 2008

Not specified 1 year Yes/yes Yes No Yes Not specified 2005 Not specified Not specified Compliance-compensated tubing; optional software upgrades.

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

17429 January 2007

72

©2008 ECRI Institute. All Rights Reserved.

Ventilators, Intensive Care Product Comparison Chart

MODEL TAEMA Horus 4 Worldwide, except USA No Yes Adult to infant 20-2,000; 5,000 1-200 0-90 1-80 0.2-5 20-90% cycle time 1:4 to 4:1 0-60% cycle time Yes 21-100 No 0-25 0-40 Yes Pressure, flow 0-30, automatic 50-150 Yes No None specified TAEMA NEFTIS icu Worldwide, except USA No Yes Adult to infant 40-2,000; 5,000 1-200 0-100 1-120 0.2-10 20-90% cycle time 1:4 to 4:1 0-60% cycle, manual Yes 21-100 No 0-50 0-40 Yes Pressure, flow 0-30, automatic 50-200 Yes Yes None specified VERSAMED/GE HEALTHCARE iVent 201 IC-AB1 Worldwide Yes Yes Adult, pediatric 50-2,000 1-120, spontaneous 180 0-80 1-80 0.2-3, adaptive time Not specified Adjustable Yes Yes 21-100 Yes 0-40 0-60 Yes Pressure, flow, dual 1-20 flow trigger, no base flow required Adjustable/auto-rise Adjustable Yes Adaptive flow, adaptive Itime, easy exhale, % flow termination, Phigh, Plow

WHERE MARKETED FDA CLEARANCE CE MARK (MDD) PATIENT TYPE CONTROLS Tidal volume, mL Inspiratory flow, L/min Inspiratory pressure, cm H2O Respiratory rate, bpm Inspiratory time, sec Expiratory time, sec IE ratio Inspiratory hold/plateau Expiratory hold FiO2, % Manual breath PEEP/CPAP, cm H2O Pressure support, cm H2O Nebulizer Trigger mechanism Bias/base flow range, L/min Pressure slope/ramp adjustment Sigh 100% O2 Others

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

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73

Ventilators, Intensive Care Product Comparison Chart

MODEL TAEMA Horus 4 OPERATING MODES Assist/control Volume breaths Pressure breaths SIMV Volume breaths SIMV Pressure breaths Pressure support Spontaneous/CPAP Pressure support Apnea-backup vent Combination modes Active/responsive valve Bilevel/APRV Others TAEMA NEFTIS icu VERSAMED/GE HEALTHCARE iVent 201 IC-AB1

Yes Yes Yes Yes Yes Yes Yes Not specified Not specified Not specified PS-PEEP with minivent rate, inverse I:E, VAPS, PRVC, APRV, noninvasive, MRV

Yes Yes Yes Yes Yes Yes Yes Not specified Not specified Not specified PS-PEEP with minivent rate, inverse I:E, noninvasive

Yes Yes Yes Yes Yes Yes Yes Yes Yes Adaptive flow in volume ventilation Yes No Adaptive bilevel (NIV)

MONITORED PARAMETERS Pressure PIP MAP PEEP Volume Tidal Minute Spontaneous minute FiO2 Respiratory rate Inspiratory time Expiratory time IE Others

Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes f/Vt, PV curve with low inflation flow method, leaks index, Pplat, VTi, VTe

Yes No Yes Yes Yes Yes Yes Yes No No No Pplat, VTi, VTe

Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Plateau pressure, autoPEEP, time constant, compliance, resistance, Rt/Vt, trending (14 parameters for 72 hr and flow over time curves, loops (pressure/volume, pressure/flow), event log

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

74

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Ventilators, Intensive Care Product Comparison Chart

MODEL TAEMA Horus 4 PATIENT ALARMS FiO2 Low minute volume Low inspiratory pressure High pressure Loss of PEEP Apnea High continuous pressure/occlusion Inverse IE High respiratory rate High minute volume High PEEP Breathing circuit disconnect Others EQUIPMENT ALARMS Gas supply failure Power failure Vent inoperative Low battery Self-diagnostics Others INTERFACING Output ports Remote alarm/display Analog output Report generation Display Hard copy Archival disk Network Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Gas disconnect Yes Yes Yes Yes (optional for UPS) Yes Messages, alarms, history RS232 (2) Yes No Optional, accessed through optional Horus MdV monitor Optional, accessed through optional Horus MdV monitor Optional, accessed through optional Horus MdV monitor Vital signs monitor TAEMA NEFTIS icu Yes Yes Yes Yes Yes Yes Yes No Yes Yes Yes Yes Gas disconnect, battery alarms Yes Yes Yes Yes Yes Messages, alarms, history RS232 (2) Yes No No No No No VERSAMED/GE HEALTHCARE iVent 201 IC-AB1 Adjustable Adjustable Adjustable Adjustable Adjustable Adjustable Adjustable Yes Adjustable Adjustable Yes Yes Leak, low tidal volume delivered Yes Yes Yes Yes Yes Flow sensor, circuit failure RS232, RJ45, VGA Yes Yes Yes Yes Yes Not specified

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

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75

Ventilators, Intensive Care Product Comparison Chart

MODEL TAEMA Horus 4 LCD (2), optional VGA color touchscreen Numbers, graphics, waveforms, trends Not specified Not specified Not specified Optional O2, air 2.8-6 bar No 10-240, 50/60 Hz 0.4 75 VA No NA NA NA NA Optional Not specified 0.5 Yes 8 20 x 43 x 44 (7.9 x 16.9 x 17.3) 14 (30) TAEMA NEFTIS icu Color touchscreen Numbers, graphics, waveforms, trends Not specified Not specified Not specified Turbine O2 2.8-6 bar Yes 10-240, 50/60 Hz Not specified 200 Yes Ni-MH (not specified) 1.5 Yes 12 Optional Any (not specified) Not specified Not specified Not specified 50 x 30 x 26 (19.7 x 11.8 x 10.2) 17 (37.5) VERSAMED/GE HEALTHCARE iVent 201 IC-AB1 Integrated color LCD Numbers, waveforms, loops, trends, event log, alarms, history MRI conditional Yes Not specified Turbine O2 40-60 psi Yes 100-240, 50/60 Hz 2.0 200 Yes Sealed lead-acid 12 V (not specified) Up to 2, depends on ventilatory parameters and impedance2 Yes ~Twice battery duration Yes 12 V deep cycle (not specified) Up to 8, depends on ventilatory parameters and impedance Yes ~8 33 x 24 x 26 (13 x 9.4 x 10.2) 10 (22.1)

DISPLAY TYPES DATA DISPLAYED MRI COMPATIBILITY SUITABLE FOR AIRCRAFT USE Approved by PNEUMATIC POWER Compressor Compressed gases Pressure ranges Turbine/piston LINE POWER, VAC Current, amps Watts INTERNAL BATTERY Type (number) Operating time, hr Rechargeable Recharging time, hr EXTERNAL BATTERY Type (number) Operating time, hr Rechargeable Recharging time, hr H x W x D, cm (in) WEIGHT, kg (lb)

This is the fourth of five pages covering the above model(s). These specifications continue onto the next page.

76

©2008 ECRI Institute. All Rights Reserved.

Ventilators, Intensive Care Product Comparison Chart

MODEL TAEMA Horus 4 PURCHASE INFORMATION List price Warranty Service Factory/on-site Training 3rd-party service Parts availability Delivery time, ARO Year first sold Number sold USA/worldwide Fiscal year OTHER SPECIFICATIONS TAEMA NEFTIS icu VERSAMED/GE HEALTHCARE iVent 201 IC-AB1

Not specified 1 year Yes/yes Yes No Yes Not specified 1997 NA/>4,000 Not specified Compliance-compensated tubing; optional software upgrades.

Not specified 1 year Yes/yes Yes No Yes Not specified 2006 Not specified Not specified Compliance-compensated tubing; optional software upgrades.

Not specified 1 year Yes/yes Yes Yes Yes Not specified 2001 Not specified January to December MRI conditional; rotationalcontrol-knob interface; VGA output for secondary-screen option; integral O2 sensor; battery backup; software upgrades via PC. Meets requirements of IEC 60601, CSA, and UL. 17429 October 2008

1iVent

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

17429 January 2007

17429 January 2007

201 IC-AB, IC, SA, AB, and home care models. 2Optional extended internal battery, up to 4 hr, depends on ventilatory parameters and impedance.

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