Ventilators, Intensive Care

7/22/2019 Ventilators, Intensive Care

1/48

February 2005

Ventilators, Intensive Care

Purpose

Ventilators provide temporary ventilatory supportor respiratory assistance to patients who cannotbreathe on their own or who require assistance tomaintain adequate ventilation because of illness,

trauma, congenital defects, or drugs(e.g., anesthetics).

In most mechanical ventilators, a positive-pressuresourcedelivers gasto thepatientslungs tosupport gasexchange; to open or maintain ventilation of alveoli,where gas exchange occurs; and to rest ventilatorymuscles until the patient is able to safely resumeadequate spontaneous ventilation. Positive-pressurebreaths are typically delivered through an endotra-cheal tube or a tracheostomytube. The pressure in thelungs increases in proportion to thevolume of inflatinggas. The pressure is relieved as gas is exhaled throughan exhalation pathway.

A high-frequency ventilator uses positive pressure

to deliver breaths at frequencies much higher thanthe normal breathing rate (e.g., >100/min). High-frequency ventilators were developed in an effort toreduce barotrauma and some of the deleterious

176169

424-008A NONPROFIT AGENCY

Scope of this Product ComparisonThis Product Comparison covers positive-pressureventilators designed for use in critical care set-tings. Although some of the models listed in thechart may have high-frequency ventilation capa-bilities, units that produce only high-frequencyventilation are not covered, nor are dedicatedneonatal/pediatric ventilators, transport ventila-tors, anesthesia ventilators, or ventilators designedexclusively for home care. For information onthese types of ventilators, see the following Prod-uct Comparisons:

Anesthesia Units Ventilators, Intensive Care, Neonatal/Pediatric

Ventilators, Portable

Ventilators, Transport

These devices are also called: critical careventilators, continuousventilators, intensivecareventilators, positive-pressure ventilators.

UMDNS information

This Product Comparison covers the following de-vice term and product code as listed in ECRIs

Universal Medical Device Nomenclature System(UMDNS):

Ventilators, Intensive Care [17-429]

5200 Butler Pike, Plymouth Meeting, PA 19462-1298, USATelephone +1 (610) 825-6000 G Fax +1 (610) 834-1275 G E-mail [email protected]


2/48

hemodynamic effects associated with the high tidalvolumes and positive pressure used with conventionalventilators. These ventilators are available for pa-tients who cannot tolerate the airway pressuresneeded for ventilation at typical volumes; they mayalso be used when a motionless field is required for

surgery near the airways.

Principles of operation

A critical care ventilator (see Fig. 1) typically con-sists of a flexible breathing circuit, a control system, agas supply, and monitors and alarms. Heating andhumidification devices are available as add-on compo-nents. Most ventilators are microprocessor controlledand regulate the pressure, volume, or flow of the deliv-ered positive-pressure breath, as well as the fractionof inspired oxygen (FiO2), based on control settings.

Communications interfaces are also typically includedso that informationon control settings,monitoredvari-ables, and alarm status can be transferred to a bedsidemonitor, an information system, or some other inter-faced device. Power is supplied from either an electri-cal wall outlet or a battery; battery power is used forshort-term ventilation, such as during intrahospitalpatient transport.

Some intensive care ventilators can receive gas(both air and oxygen [O2]) from a wall outlet thatgenerally provides gas at a pressure of approximately50 pounds per square inch (psi); the flow of gas to the

patient can be regulated by flow-control valves on theventilator. To obtain the desired FiO2 for delivery tothe patient, most ventilators mix air and O2 internally.During inspiratory gas delivery, an exhalation valve isclosed to maintain pressure in the breathing circuitand lungs. The gas is delivered to the patient through the

flexible breathing circuit. Most intensive care ventila-tors use a double-limb breathing circuit made of corru-gated plastic tubing to transport the gas from theventilator to the patient and return the exhaled gas tothe ventilator through one of the limbs (referred to asthe expiratory limb). During inspiratory gas delivery,the exhalation valve is closed to maintain pressure in

the breathing circuit and lungs. After the inspiratoryphase, the gas is released to ambient air through thisvalve. The breathing circuit also provides sites wherethe delivered gas may be heated; humidified; moni-tored for proximal airway pressure; and conditionedwith nebulized medications, as well as where conden-sation may be collected. Many models have sensorswithin the ventilator or breathing circuit that canmeasure airwaypressure or flow and provide feedbackto the ventilator to automatically adjust its output.

Patient

Breathing Circuit

Inhalation

Exhalation

ExhalationPort

Controls/

Monitors/Alarms

GasSupply

ExhalationValve

C420UN3A

Figure 1. Typical ventilator system

Healthcare Product Comparison System

2 2005 ECRI. Duplication of this page by any means for any purpose is prohibited.


3/48

Controls

Controls are used to select breathing mode andventilation pattern parameters (e.g., tidal volume,breathing rate). For the ventilator to produce a pre-scribed breathing pattern, several parameters can be

independently set, such as length of the inspiratory orexpiratory phase, rate of mechanical breaths, ratio ofinspiratory time to expiratory time (I:E ratio), wave-form shape, tidal volume, minute volume (the volumeinhaled in one minute), peak inspiratory flow, peakpressure, and positive end-expiratory pressure(PEEP).

Intensive care ventilators have continuous positiveairwaypressure (CPAP) andPEEP controls, which areregulated by a restriction of flow to the exhalationvalve.CPAP provides continuous positive airway pres-sure in the breathing circuit as the patient breathesspontaneously. This keeps the alveoli and airwaysinflated by preventing proximal airway pressure fromreturning to zero at the end of exhalation. CPAP isapplied to patients who canbreathe spontaneously anddo not require full ventilatory support. It can improvelung volume and, consequently, oxygenation and lungfunction by increasing alveolar volumes, recruitment,and stability. By helping to redistribute interstitialwater, CPAP also improves O2 diffusion across thealveolar capillary membrane. CPAP may be used toraise the patients arterial partial pressure of oxygen(PaO2) without requiring an increase in the FiO2.

PEEP maintains a positive airway pressure from theend of an assisted, controlled, spontaneous, or manda-tory exhalation to the beginning of the next inspira-tion. The result is similar to that obtained with CPAPand is achieved by restricting or prohibiting the exha-lation of gases through the exhalation valve after thepressure has dropped to a prescribed value. PEEP aidsin maintaining lung volumeandin preventing alveolarcollapse. Increases in PEEP are often used to increasethe patients arterial O2 saturation without increasingthe inspired O2 percentage, although very high PEEPmay decrease venous return, cardiac output, and O2transportand increasepulmonaryvascularresistance.

The I:E ratio is an indication of the partitioning of abreath into inspiration and expiration. In general, theexpiratory time is set to be longer than the inspiratorytime (e.g., I:E ratio is 1:2); however, an inverse ratiocan also be used so that the inspiratory time exceedsthe expiratory time (e.g., I:E ratio is 1:0.5). Becauseinverse I:E settings are not normally used, some ven-tilators signal when an inverse I:E ratio has beenreached; others will not deliver inverse I:E breaths.

Controls arealso availableforsetting theflow wave-form. Volume-controlled ventilation flowgenerallyhassquare, accelerating, decelerating, or sinusoidal wave-forms. Pressure ramp adjustments are now availablein pressure-controlled ventilation modes. Such adjust-ments allow the user to maximize the flow and pres-

sure levels while maintaining a flow delivery thatlowers the work of breathing and is more comfortablefor the patient.

Operating modes

Intensive care ventilators have several operatingmodes; a mode of operation defines the algorithm thatwill be used to initiate (or trigger) and end a machinebreath. Different modes can provide either full or par-tial ventilatory support, depending on the individualpatients condition and respiratory ability.

The control mode provides full support to patientswho cannot breathe for themselves; it is infrequentlyused. In this mode, the ventilator provides mandatorybreaths at preset time intervals and does not allow thepatient to breathe spontaneously. This mode requiresthe patient to be unconscious or sedated to stop spon-taneous attempts to breathe asynchronously with theventilator.

Assist/control modes also provide full support bydelivering an assisted breath whenever the ventilatorsenses a patients inspiratory effort and by deliveringmandatory breaths at preset time intervals. In thismode, the ventilator delivers a patient-assisted breathwhen it sensesa patientsinspiratory effort. This modeis designed for patients who have difficulty breathingbutcaninitiate inspiration.A breath is triggeredwhena patients breathing efforts are detected as a drop inpressure in the breathing circuit (pressure triggering)or as a difference in flow between the circuits inspira-toryand expiratory limbs(flow triggering). Ventilatorscan use one or both of these methods of triggering.

Most intensive care ventilators can deliver volume-and pressure-controlled breaths that can be used toprovide both full and partial ventilatory support. Vol-ume-controlled breaths of ventilation use a control

system to ensure that a set tidal volume is deliveredduring the inspiratory cycle. The set volume may notbe delivered if the pressure exceeds the setting of thehigh-pressure alarm or of a pressure-relief valve.These modes are typically used for adult and pediatricpatients to maintain adequate pulmonary gas ex-change. Pressure-controlled breaths regulate flow de-livery to attain and sustain a clinician-set inspiratorypressure level for a set time so that the ventilatordelivers controlled or assisted breaths that are time


2005 ECRI. Duplication of this page by any means for any purpose is prohibited. 3


4/48

cycled. Combination modes, which are now available onseveral models, combine volume- and pressure-controlledventilation to ensure that a minimum volume is deliv-ered with an initial flow that matches patient demand.These modes may allow more effective ventilation ofpatients whose lung characteristics change frequently.

The synchronized intermittent mandatory ventila-tion (SIMV) mode delivers controlled breaths at a setfrequency and also allows the patient to breathe spon-taneously with no assistance during the periods be-tween the controlled breaths. The mandatory breathsin this mode are synchronized with a spontaneousbreathing effort if that effort occurs sufficiently closeto the time the mandatory breath would have beenproduced. This reduces the possibility of overinflation,which could result from stacking a mandatory breathon a spontaneous breath.

Pressure support reduces the work of spontaneous

breathing by delivering a preset level of positive pres-sure to the patients airway during a spontaneousinspiratory effort. This reduces the work of the pa-tients respiratory muscles and minimizes the effortneeded to draw an adequate amount of air into thelungs. It also compensates fortheextra work of breath-ing imposed by the ventilator tubing and valves. Pres-sure support is an adjunct that may be added tospontaneous efforts in the SIMV and CPAP modes.

Another mode of ventilation is airway pressure re-lease ventilation (APRV). APRV may be used to treatacute lung injury in patients who require mechanical

support. Once an appropriate level of CPAP is se-lected, APRV is initiated whenever mechanical assis-tance is required by cyclically releasing the airwaypressure until a lower level is obtained.Carbondioxideexits the lungs passively as the airway pressure de-creases. When this brief release period ends, the air-way pressure rapidly returns to the CPAP level. Thismodeprovidesmechanical ventilatory assistancewith-out raising the airway pressure above the CPAP level;consequently, barotrauma and adverse hemodynamiceffects may occur less frequently than with other con-ventional modes of mechanical ventilation.

Monitors and alarms

Intensivecare ventilators areequippedwith a varietyofmonitors andalarmstodetectequipment-relatedprob-lems and changes in patient status, to ensure that theuseradjustssettingsto achieveeffectiveventilation,andto reduce the risk of ventilator-induced injury (e.g., baro-trauma). Variables that are typically monitored anddisplayed on the ventilator include the following:

A continuous indication of airway pressure, as wellas 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 volumeover one minute (exhaled minute volume)

Graphics monitors include graphs of pressure, vol-ume, and flow versus time. To track the patientsprogress, the monitor calculates patient pulmonarymechanics (e.g., compliance, resistance) from moni-tored variables. Pressure-volume loops, which aregraphs of pressure versus volume over a single breath,andflow-volume loops, which aregraphsof flow versusvolume over a single breath, indicate breathing abnor-malitiessuch as obstructiveor restrictive lung disease.Graphics monitors are generally part of the ventilatorunit. If not, the manufacturer usually sells one withthe unit.

Graphics monitors allow the clinician to optimizeventilator settings values and assist with diagnostics.The displayed loops and lung mechanics parameterscanalsohelpcliniciansrecognizeobstructive or restric-tive flow patterns.

Because theconsequences of incorrector inadequatemechanical ventilation can be severe, ventilators areequipped with audible and visual alarms to notifyclinicians of changes in the patients condition or ofdevice problems. Most ventilators have alarms for ap-

nea, high and low respiratory rate, high and low pres-sure, loss of power, loss of high-pressure gas, systemmalfunctions, incorrect O2 concentration, and exhaledvolume. Some ventilators also have baseline-pressurealarms; the low-baseline-pressure alarm alerts clini-cians to losses of PEEP, which can affect the patientsO2 saturation, and the high-baseline-pressure alarmalerts clinicians to inadvertent increases in PEEP,which can prevent complete exhalation. An alarmshould also be activated if disconnections occur in thebreathing circuit or if flow resistance is encountered.

A loss of power or the gas supply, or other conditionsaffecting a ventilators ability to operate, should pro-

duce an alarm and allow the patient to spontaneouslybreathe air or the specified gas mixture. All criticalalarms should be easy to identify and impossible todisarm indefinitely.

Additionally, to prevent injury to the patient untilclinicians can respond to alarms, ventilators incorpo-rate a number of safety features such as the ability torelease pressureat thelevelof thehigh-pressure alarmsetting. Another feature is the presence of backupventilation, in which the ventilator will initiate




5/48

breaths when it senses that the patients breathingefforts have ceased.

Alarm-enhancement systems

Ventilator alarms are crucial for safeguarding thehealth and lives of patients. Therefore, it is vital that

they be readily detected in even the busiest, noisiesthospital departments. Alarm-enhancement systems,which communicate ventilator alarms to locationswhere they aremore likelytobedetectedbycaregivers,can be helpful.

There are four basic categories of ventilator alarmenhancements:

Interfacing ventilators with physiologic monitors

Incorporating commercially available systems forcentralized monitoring of ventilator alarms

Interfacing ventilators with nurse call systems

Utilizing remote annunciators for ventilator alarms

The various alarm-enhancement options rangewidely in complexity, cost, and the types of care set-tings for which theyre likely to be suitable. For moreinformation on alarm-enhancements systems andventilator-physiologic monitoring system interfaces,see the Health Devices citation below.

Communication interfaces

Most intensive care ventilators have a standard oroptional interface through which the ventilator can beconnected to a bedside monitor or information system.

Ventilator settings, monitored variables, and informa-tion on alarms can be transmitted through this inter-face. On some units, the interface can connect twoventilators, synchronizing them so that they can inde-pendently ventilate both lungs (e.g., for a patient withunilateral lung disease).

Reported problems

The most common problem associated with inten-sive care ventilators is the risk of a patient acquiringventilator-associated pneumonia (VAP). It is gener-ally accepted that prolonged ventilation periods

greatly increase a patients risk of acquiringVAP. Thelink between prolonged ventilation and VAP is un-clear, but followingproper infectioncontrol proceduresin maintaining the ventilator, the breathing circuit,and all associated equipment can minimize patientrisk.

Leaks in the breathing circuit or components mayprevent the ventilator from delivering a preset tidalvolume or accurately sensing flow and terminating apressure-supported breath. Also, such leaks can affect

the ventilators ability to maintain the PEEP level.This in turn may affectO2 saturation and can result inautocycling.

The friction-fit connector that attaches a ventilatorto a patients artificial airway can be accidentally dis-

connected if it is not attached securely by theclinician.Ventilators should signal an audible and visual alarmwhen they detect a leak or disconnection; however,some low-pressure alarms can be inappropriately ad-

justed below the detection threshold.

Patient-ventilator dyssynchrony refers to the situ-ation in which a mechanically ventilated patient failsto trigger the ventilator, or the ventilator erroneouslysenses a patients effort and delivers breaths. Theresult is a machine breath rate that is inappropriate tothe rate of the patients inspiratory efforts. This is alsocalled trigger failure or desynchronization, mismatch-

ing, and fighting the ventilator. One cause for pa-tient-ventilator dyssynchrony is improper setting oftrigger sensitivity.Theuseof airwaypressureandflowwaveforms todetect itmaynotbereliable,sinceairwaypressure and flow measured at the ventilator can beaffected by various artifacts (e.g., hiccups, coughs,sudden displacement or compression of the ventilatortubing). Clinical observation is highly specific in iden-tifyingpatient-ventilatordyssynchrony,sinceobserva-tion of thoracoabdominal movement has been thestandard method of determining respiratory rate, andpatients with patient-ventilator dyssynchrony oftenhave heightened and prominent accessory muscle ac-tivity associated with inspiratory efforts. When gasdelivery is not synchronized with the patients effortsto initiate a breath, increased patient discomfort andwork of breathing can result. This can also lead torespiratory distress, can inhibit pulmonary gas ex-change, and can make weaning the patient from me-chanical ventilation more difficult.

Because in many cases the patient depends entirelyon the ventilator for life support, ensuring propermaintenance and avoiding operator errors or machinefailures can be critical. Some of the unavoidable risks

of mechanical ventilation include barotrauma (whenanairway pressurethat is toohighdamages thelungs),reduced cardiac output, and adverse effects on gasexchange in the lungs. By using a well-designed venti-lator and ensuring that it is set up and operatedcorrectly, users can typically avoid injury to the pa-tient. In addition,ventilators aretypically inspectedatleast semiannually, and operation is usually verified(orshould be)beforeeach use. These procedures shoulddetectmost cases of inappropriate setup or mechanicalproblems.




6/48

Purchase considerations

ECRI recommendations

Included in the accompanying comparison chart areECRIs recommendations for minimum performancerequirements for intensive care ventilators. The re-

quirements are separated into two categories basicand mid/high complexity.

The ventilator should offer assist/control and SIMVmodes.Forvolumeandpressurebreaths, it shouldalsoprovide CPAP/PEEP and pressure support. The unitshould monitor airway pressure, respiratory rate, I:Eratio, and minute volume; controls should be availablefor pressure level, tidal volume, breath rate, inspira-tory time, FiO2, PEEP/CPAP, I:E ratio, pressure sup-port, and sensitivity.

Alarms, both visual and auditory, should be avail-able for inspiratory pressure (low and high), low

CPAP/PEEP, minute volume (low or low/high), respi-ratory rate (low and high), gas supply loss, and powerfailure. All alarms should be distinct and easily iden-tified. Also, if alarm volume is adjustable, it should notbe possible to turn the volume down so low that thealarm is inaudible. The alarm silence feature mustreactivate automatically within two minutes if thecondition is not corrected. If an alarm is silenced, avisual display should clearly indicate which alarm isdisabled.

The delivered O2 or O2/air mixture should be moni-tored with an O2 analyzer that includes an alarm for

concentrations outside acceptable ranges. The ana-lyzer should be included with the ventilator.

The controls (i.e., switches and knobs) should bevisible and clearly identified, and their functionsshould be self-evident. The design should prevent mis-interpretation of displays and control settings. Con-trols should be protected against accidental settingchanges (e.g., due to someone brushing against thepanel) and be sealed against fluid penetration. Patientand operator safety and system performance shouldnot be adversely affected by fluid spills.

Other considerations

Current ventilator designs offer an often compli-cated variety of options, requiring a knowledgeableuser. Staff shortages and frequent employee turnoverin some hospitalsoften make adequate formal trainingin the use of clinical equipment difficult. Therefore,ventilators with good human factors design offer asignificant advantage. In addition, standardizingequipment helps minimize retraining and confusion,and suppliers often give significant discounts whenmultiple units are purchased.

A wide range of modes, variables monitored andcontrolled, and alarms is offered among different ven-tilators. These features should be evaluated to deter-mine which are needed for a particular patientpopulation and clinical setting.

Cost containmentBecause intensive care ventilators entail ongoing

maintenance and operational costs, the initial acquisi-tion cost does not accurately reflect the total cost ofownership. Therefore, a purchase decision should bebased on issues such as life-cycle cost (LCC), localservice support, discount rates and non-price-relatedbenefits offered by the supplier, and standardizationwith existing equipment in the department or hospital(i.e., purchasing all ventilators from one supplier).

An LCC analysis can be used to compare high-costalternatives and/or to determine the positive or nega-

tive economic value of a single alternative. For exam-ple, hospitals can use LCC analysis techniques toexamine the cost-effectiveness of leasing or rentingequipment versus purchasing the equipment outright.Because it examines the cash-flow impact of initialacquisition costs and operating costs over a period oftime, LCC analysis is most useful for comparing alter-natives with different cash flows and for revealing thetotal costs of equipment ownership. One LCC tech-nique present value (PV) analysis is especiallyusefulbecause it accounts for inflationandforthe timevalue of money (i.e., money received today is worthmore than money received at a later date). Conductinga PV/LCC analysis often demonstrates that the cost ofownership includes more than just the initial acquisi-tion cost andthat a small increase in initial acquisitioncost may produce significant savings in long-term op-erating costs. The PV is calculated using the annualcash outflow, the dollar discount factor (the cost ofcapital), and the lifetime of the equipment (in years) ina mathematical equation.

The following represents a sample seven-yearPV/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%

Inflation rate is 4% for disposables

Inflation rate is 6% for a full-service contract

Disposable breathing circuits are changed once aweek




7/48

Capital Costs

Ventilator = $23,000

Total Capital Costs = $23,000

Operating Costs

Disposables = $1,040/year ($20 disposable breath-ing circuits and accessories are changed once aweek)

Service contract, years 1 through 7 = $1,100/year

Total Operating Costs = $2,140/year

PV = ($37,184)

Other costs not included in the above analysis thatshould be considered for budgetary planning includethose associated with the following:

Reusable breathing circuits

Disinfection of reusable breathing circuits

Partsreplaced during preventivemaintenance (e.g.,sensors)

Staff training

Utilities

Contributions to overhead

Clearly, the expected expense of operating an inten-sive care ventilator is significantly greater than theinitial cost of the device. Hospitals should evaluatehow they plan to use the ventilator; in particular, thedecision to use disposable or reusable breathing cir-cuits will affect the cost of operation.

Hospitals can purchase service contracts or serviceon a time-and-materials basis from the supplier. Serv-ice may also be available from a third-party organiza-tion. Thedecision to purchase a service contract shouldbe carefully considered. Purchasing a service contractensures that preventive maintenance will be per-formed at regular intervals, thereby eliminating thepossibility of unexpected maintenance costs. Also,many suppliers do notextend systemperformanceanduptime guarantees beyond the length of the warranty

unless the system is covered by a service contract.

ECRI recommends that, to maximize bargainingleverage, hospitals negotiate pricing for service con-tracts before the system is purchased. Additional serv-ice contract discounts may be negotiable formultiple-year agreements or for service contracts thatarebundled with contracts on other similar equipmentinthedepartment orhospital.Forcustomized analysesand purchase decision support, readers should contactECRIs SELECT Group.

Stage of development

The mid-1980s witnessed the introduction of micro-processor-based ventilators that could be easily up-graded to perform additional operations by a simplesoftware change. However, the use of microprocessorshas given the operator a vast and sometimes confusingnumberof options tochoosefrom.Overthenextseveralyears, monitors for gas exchange and hemodynamicsmay be merged with the ventilators existing datacollectionsystem. This combined system mayalert theclinician to necessary control changes.

Recently, the concept of tracheal triggering wasintroduced. Tracheal pressure triggering can substan-tially reduce the work of breathing in lung modelsstimulating spontaneous breathing with CPAP. Thisreduction occurs because a small level of pressuresupport is produced at theproximal endotrachealtube.Tracheal triggering may also be beneficial when small

endotracheal tubes are used.

There has been a recent trend to collect and storeinformation from medical devices electronicallyand todisplay information from one device on another. TheInstitute of Electrical and Electronics Engineers hasbeen developing a standard communication protocolcalledthemedical information bus, whichallowsmanytypes of medical devices to communicate with eachother and to transfer data in a standardized format.Institutions with more than one brand of ventilatormaythereby be able to automate their respiratory carecharting.

In addition, most ventilators now offer a noninva-sive delivery option. This option delivers ventilationusually through a mask that fits over the mouth andnose.

Bibliography

Branson R. Understanding and implementing ad-vances in ventilator capabilities. Curr Opin CritCare 2004 Feb;10(1):23-32.

Branson RD, Campbell RS. Sighs: wasted breath orbreathof freshair?RespirCare1992 May;37(5):462-8.

Calzia E, Lindner KH, Stahl W, et al. Work of breath-ing, inspiratory flow response, and expiratory resis-tance during continuous positive airway pressurewith the ventilators EVITA-2, EVITA-4, and SV300. Intensive Care Med 1998 Sep;24(9):931-8.

Chao DC, Scheinhorn DJ, Stearn-Hassenpflug M.Patient-ventilator trigger asynchrony in prolongedmechanical ventilation. Chest 1997 Dec;112(6):1592-9.




8/48

Cook D, De Jonghe B, Brochard L, et al. Influence ofairway management on ventilator-associated pneu-monia: evidence from randomized trials. JAMA1998 Mar 11;279(10):781-7.

Del Valle RM, Hecker RB. A review of ventilatory

modalities used in the intensive care unit. Am JAnesthesiol 1995 Jan-Feb;22(1):23-30.

Fenstermacher D, Hong D. Mechanical ventilation:what have we learned?Crit Care Nurs 2004Jul-Sep;27(3):258-94.

Goulet R, Hess D, Kacmarek RM. Pressure vs flowtriggering 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 pres-

sure support ventilators: effect of triggering methodand bias flow. Respir Care 1997 Oct;42(10):952-9.

Joiner GA, Salisbury D, Bollin GE. Utilizing qualityassurance as a tool for reducing the risk of noso-comial ventilator-associated pneumonia. Am J MedQual 1996 Summer;11(2):100-3.

MacIntyreNR, McConnell R, Cheng KC, et al.Patient-ventilator flow dyssynchrony: flow-limited versuspressure-limited breaths. Crit Care Med 1997 Oct;25(10):1671-7.

Vitacca M. New things are not always better: propor-

tional assist ventilation vs. pressure support venti-lation. Intensive Care Med 2003 Jul;29(7):1038-40.

Wilkins RL, Stoller JK. Egans fundamentals of respi-ratory care. 8th ed. St. Louis: CV Mosby; 2003.

Standards and guidelines

Note: Although every effort is made to ensure that thefollowing list is comprehensive, please note that other

applicable standards may exist.

American Association for Respiratory Care. Endotra-cheal suctioning of mechanically ventilated adults

and children with artificial airways [guideline].Respir Care 1993 May;38(5):500-4.

Humidification during mechanical ventilation[guideline]. Respir Care 1992 Aug;37(8):887-90.

Patient-ventilatorsystem checks [guideline].RespirCare 1992 Aug;37(8):882-6.

ASTM International. Specification for ventilators in-tended for use in critical care [standard]. ASTMCommittee F29 on Anesthetic and RespiratoryEquipment. F1100-90. 1990.

Danish Standards Association/European Committeefor Standardization. Breathing tubes intended foruse with anaesthetic apparatus and ventilators[standard]. DS/EN 12342. 1998.

Lung ventilators part 1: particular requirementsfor critical care ventilators [standard]. DS/EN 794-1.1997.

International Electrotechnical Commission. Medicalelectrical equipment part 1: general require-ments for safety [standard]. IEC 60601-1 (1988-12).1988.

Medical electrical equipment part 1: general re-quirements for safety. Amendment 1 [standard].IEC 60601-1-am1 (1991-11). 1991.

Medical electrical equipment part 1: general re-quirements for safety. Amendment 2 [standard].IEC 60601-1-am2 (1995-03). 1995.

Medical electrical equipment part 1-1: generalrequirements for safety. Collateral standard: safetyrequirements formedical electrical systems. 2nded.IEC 60601-1-1 (2000-12). 1992 (revised 2000).

Medical electrical equipment part 1-2: generalrequirements for safety. Collateral standard: elec-tromagnetic compatibility requirements andtests. IEC 60601-1-2 (2001-09). 1993 (revised 2001).

Medical electrical equipment part 2-12: particu-lar requirements for the safety of lung ventilators[standard]. IEC 60601-2-12 (2001-10). 2001.

International Organization for Standardization. An-aesthetic and respiratory equipment. Heat andmoisture exchangers (HMEs) for humidifying re-spired gases in humans. Part 1: HMEs for use withminimum tidal volumes of 250 ml [standard]. ISO9360-1:2000. 2000.

Anaesthetic and respiratory equipment. Heat andmoisture exchangers (HMEs) for humidifying re-spired gases in humans. Part 2: HMEs for use withtracheostomized patients having minimum tidalvolumes of 250 ml [standard]. ISO 9360-2:2001.2001.

Lung ventilators for medical use part 1: require-

ments [standard]. ISO 10651-1:1993. 1993.

Citations from other ECRI publications

Health Devices

Minimum requirements for respiratory careventilatortesting [guidance article]. 1996 Sep-Oct;26(9-10):383-4.

Intensive care ventilators [evaluation]. 1998 Sep-Oct;27(9-10):308-62.




9/48

Minimum requirements for ventilatory testing [guid-ance article]. 1998 Sep-Oct;27(9-10):363-4.

Intensive care ventilators [update evaluation]. 2000Jul-Aug;29(7-8):249-73.

Listen up musical ventilator alarms must be an-

swered! [hazard report]. 2000 Nov;29(11):438.Ventilator power cords are lifelines that need careful

inspection [hazard report]. 2001 Jul;30(7):262-3.

Unique configuration of Siemens Servo 300 and 300Aventilators could cause lung injury hazard report.2002 Jul;31(7):270-1.

Erratic control knobs affect Siemens Servo 300 and300A ventilators [hazard report]. 2002 Dec;31(12):457-9.

Intensive care ventilators [evaluation]. 2002 Dec;31(12):441-54.

Rainout puts ventilator-dependent patients at risk[hazard report]. 2002 Dec;31(12):461-3.

Close-range EMI sends Nellcor Puritan Bennett 840ventilators into Vent Inop mode [hazard report].2003 Mar;32(3):128-30.

Alarm-enhancement systems for ventilators [guidancearticle]. 2004 Jan;33(1):5-23.

Disconnecting wall gas can interrupt ventilation onDrger Evita 2 dura and Evita 4 ventilators [hazardreport]. 2004 Jan;33(1):26.

Alarm-enhancement systems for ventilators: problems

with physiologic monitoring interfaces. 2004 Oct;33(10):354-5.

Health Devices Alerts

This Product Comparison listsHealth DevicesAlerts(HDA) citations published since the last update of thisreport. Each HDA abstract is identified by an Acces-sion Number. Recalls and hazard reports include de-scriptions of the problem involved; abstracts of otherpublished articles are referenced by bibliographic in-formation. HPCS subscribers can call the Hotline foradditional information on any of these citations or torequest more extensive searches of the HDA database.

A5510 Hamilton has recently found that third-partycompanies are distributing flow sensors in the U.S.that look like Hamilton Medical flow sensors. Third-party flow sensor promotional information might im-ply that these flow sensors are authorized for use withHamilton Medical ventilators. Hamilton considers thesubstitution of any unauthorized critical components,such as the flow sensor, to be a potentially dangerousand off-label use of its ventilators. Hamilton has nottestedanythird-party flow sensors with its ventilators

to demonstrate their safety and effectiveness. IfHamilton Medical ventilators are used with flow sen-sors that do not meet Hamiltons design and perform-ance specifications, the delivered tidal volume, minutevolume, airway flow, and pressure delivery may beinaccurate. Clinical conditions such as hyper- or hy-

poventilation, hyperinflation, auto positive end-expi-ratory pressure, high airway resistance, flow andpressure trigger problems, and false-alarm detectionmay result if inaccurate flow sensor data is processedby Hamilton Medical ventilators. The manufacturerissued a corrective action notice and flow sensor iden-tification sheet dated December15,2003. Users shouldverify that they have received the December 15, 2003,letter and descriptive document from Hamilton. Iden-tify and isolate any affected product in your inventory.

Authorized Hamilton Medical flow sensors are identi-fied by the standard Hamilton blue color and productlabeling. The Hamilton Medical trademark logo ap-

pears on all device labeling and is molded into thedevice housing. Third-party flow sensors will not con-tain the Hamilton Medical labeling or logo, and theunauthorized flow sensor housing is generally madefrom a clear/transparent plastic. Hamilton recom-mends that you immediately discontinue use of anythird-party flow sensors being used with anyHamiltonmedical ventilators.

Although alternate-supplier devices have not beentested by Hamilton for use with its ventilators, ECRIbelieves that use of these devices should not necessar-ily be ruled out. We recommend that each institution

research the product they are going to purchase forsafety and quality before deciding which product isbest for their purposes. For additional assurance, werecommend that you request and obtain a letter fromthe alternate supplier stating that the device beingused has demonstrated compatibility with the originalequipment manufacturers device and that it is FDA510(k) cleared. When using any medical device, it isimportantthat all safetywarnings andinstructionsforuse are read and followed carefully. Should an adverseevent occur during use of an alternate suppliers prod-uct, it is important to be aware that the original manu-facturer may claim no liability for the incident.

Hospitals should develop policies on ordering partsfrom alternate-parts suppliers and provide adequatedocumentation of the decision-making process, espe-cially concerning the determination of acceptable per-formance and safety. Source: Letter submitted byECRI member hospital; Manufacturer.

A5690 ECRI reported that Draeger issued an Impor-tant Information letter dated May 7, 2003, which ad-dressed the following: (1) spontaneous modality orparameter changes in Evita 4 continuous ventilator




10/48

software version 4.00, (2) system responses that occurwith the Ideal Body Weight configuration in softwareversions 4.00 and 4.10, and (3) inadvertent activationof a device-failure alarm when changing the defaultstart-up setting for AutoFlow to off while ventilationis active. Draeger issued an additional Important Infor-

mation letter dated April 16, 2004, to announce thatsoftware version 4.14, which eliminates these problems,is now available. Users should verify that you havereceived the April 16, 2004, letter from Draeger. Identifyany affected product in your inventory. Source: Lettersubmitted by member hospital; Manufacturer.

A5889 FDAhasdesignatedClassI RecallNo.Z-1485-04certain Pulmonetic Systems ventilators. The ventila-tors may stop functioning when switching to internaldirect-current (DC) battery power because of an inade-quate external power source. Loss of ventilator func-tion could lead to patient death or permanent

neurologic injury if users and caregivers do not followthe device user instructions and do not know how toreact in this scenario. The manufacturer has receivedapproximately 30 reports of this problem (involving0.3% of devices) that did not result in patient injurybecause of prompt caregiveraction. The manufacturerhas also received 1 report of a patient death possiblyassociated with this problem that remains under in-vestigation. Normally, the ventilators function prop-erly from an external alternating-current (AC)adapter, internal DC battery, or external DC bat-tery/automobile power source and are able to switchfrom an external power source to an internal sourcewithout interruption of function. The manufacturerexpects to provide a permanentsolution forall affecteddevices that will be easily installed by caregivers orusers beginning in late October 2004. The firm initi-ated a recall by letter dated September 7, 2004, andpress release dated September 27, 2004. Verify thatyou have received the September 7, 2004, letter andcaregiver information sheet and the September 23,2002, product bulletin titled Getting the most fromyour Pulmonetic Systems batteries from PulmoneticSystems. Identify any affected product both in yourinventory and already distributed to patients. Distrib-

ute the caregiver information sheet to all affectedpatients. Until the manufacturer provides a perma-nent solution for this problem, users and caregiversshould read the caregiver information sheet to knowhow to react in the event of a malfunction. Addition-ally, users and caregivers can minimize the risk ofventilator malfunction by following the recommenda-tions regarding proper use and management of thedevices external power sources in the September 23,2002, product bulletin and the device operators man-ual (PN 10664). Users can also minimize the risk of

physical harm to patients by always being prepared toprovide alternative ventilationmethods in theevent ofa ventilator malfunction. Users should also learn torecognize the 2 alarms that may sound if the abovedevices malfunction because they are not adequatelypowered by a stable external battery or automobile

cigarette lighter accessory power source. The firstalarm, or vent reset alarm, can be identified by thefollowing characteristics: (1) The ventilator audiblealarm will sound,andall front-paneldisplay lightswillturn on for approximately 1 sec. (2) The audible alarmwill silence, and the front-panel display will readSRAM ROM CRC POST passed. (3) The red VentINOP light will display on the front panel and thenturn off. (4) Sequence 1 through 3 will repeat every3.5 sec. The second alarm, or vent INOP alarm, canbe identified by the following characteristics: (1) Thefront-panel display lights will turn on and off abruptlyor will blink on and off repeatedly. (2) The red Vent

INOP light will become visible on the front-paneldisplay. (3) The audible alarm will sound continu-ously. If either the vent reset or the vent INOPalarm sounds, the patient is not being ventilated, andusers should immediately disconnect the externalpower cable from the pigtail connector. If the ventila-tor does not resume proper function on its own, restartthe device by pressing the On/Standby button on thefront of the device. The ventilator should functionproperly with theinternal battery after theinadequateexternal power source is removed. Replace the venti-lators battery before operating it with a DC powerconnector if the vent reset or vent INOP alarmoccurs while the device is connected to an externalbattery. If either alarm sounds while the device isconnected to an automobile cigarette lighter accessorypower source, stop powering the ventilator with thatelectrical source because it may be inadequate. In thefuture, use a new external battery during transport,and always travel with an emergency external batterykit in case the automobile cigarette lighter accessorypower sourcefails. Youmay also connect theventilatorto the AC adapter after the DC power connection hasbeen detached. Never use external battery sources orDC power cables that have not been distributed or

recommended by Pulmonetic Systems. Identify andisolate any damaged power cables or nearly dead bat-teries. Source: FDA Enforcement Rep 2004 Sep 29;United States. Food and Drug Administration. Centerfor Devices and Radiological Health. Medical devicerecalls. Class I recall: Pulmonetic Systems LTV seriesof ventilators [online]. 2004 Sep 8 [cited 2004 Oct 11].

Available from Internet: http://www.fda.gov/cdrh/recalls/recall-090804.html; United States. Food andDrug Administration. Center for Devices and Radiologi-cal Health. Pulmonetic Systems, Inc. issues nationwide




11/48

recall of certain LTV ventilators [press releaseonline].2004 Sep 27 [cited 2004 Oct 11]. Available from In-ternet: http://www.fda.gov/cdrh/recalls/recall-090804-pressrelease.html; letter submitted by ECRI memberhospital; Manufacturer.

D6385 FDA has issued a warning letter to the Respi-ronics manufacturing facility in Carlsbad, California,that addresses the classification and reporting of cor-rective field actions taken by Respironics in 2001 con-cerning check-valve failures for certain ventilators.Forexample, themanufacturerperformedfield correc-tions to eliminate problems associated with torn andseparated check valves. In addition, the manufac-turers investigation determined that the materialhardness of thecheck valve made thevalve susceptibleto tearing after 2,800 hr of operation and that anorientation problem subjected the valve to unduestress in its hinged area. The manufacturer changed

both the orientation and the hardness of the checkvalve to improve durability. The manufacturer alsohadservice representativesreplace thecheck valves inall distributed devices and adjust the orientation. Themanufacturer did not originally initiate the field cor-rections as part of official recalls. The field correctionshave since been reported to FDA, and the recalls arecomplete. The manufacturer states that no affectedproduct remains on the market. No further action isrequired of customers. The FDA warning letter alsoaddresses issues concerning the fact that the methodsused in, or the facilities or controls used for, manufac-turing, packing, storing, or installing the above venti-

lators do not conform with Good ManufacturingPractices requirements. The manufacturer states thatit takes these issuesseriouslyandisworking with FDAto resolve each point raised in the warning letter.Source: Letter submitted by manufacturer; UnitedStates. Food and Drug Administration. Warning letteronline. 2004 Jan 27 cited 2004 Mar 11. Available fromInternet: http://www.fda.gov/foi/warning_letters/g4514d.htm.

40278 Donaldson L, Dodds S, Walsh TS. Clinicalevaluation of a continuous oxygen consumption moni-tor in mechanically ventilated patients. Anaesthesia

2003 May;58(5):455-60.40707 Samore MH, Evans RS, Lassen A, et al. Sur-veillance of medical device-related hazards and ad-verse events in hospitalized patients. JAMA 2004 Jan21;291(3):325-34.

40721 Petter AH, Chiolro RL, Cassina T, et al.Automatic respirator/weaningwith adaptive supportventilation: the effect on duration of endotracheal in-tubation and patient management. Anesth Analg 2003Dec;97(6):1743-50.

40817 Rosenthal VD, Guzmn S, Crnich C. Device-associated nosocomial infection rates in intensive careunitsof Argentina.Infect Control Hosp Epidemiol2004Mar;25(3):251-5.

Health Devices Inspection and Preventive Maintenance

SystemCritical care ventilators. Procedure no. 458.

The Risk Management Reporter

JCAHO, ECRI offer advice to prevent ventilator-related deaths, injuries. 2002;21(3):9.

VHA program improves ICU care and outcomes, re-duces risks. 2004;23(1):10-1.

Supplier information

Acoma

Acoma Medical Industry Co Ltd [152410]2-14-14 HongoBunkyo-kuTokyo 113-0033JapanPhone: 81 (3) 38166911Fax: 81 (3) 38143845E-mail: [email protected]: http://www.acoma.com

Bio-Med Devices

Bio-Med Devices Inc [104004]

1445 Boston Post RdGuilford CT 06437Phone: (203) 458-0202, (800) 224-6633Fax: (203) 458-0440E-mail: [email protected]: http://www.biomeddevices.com

Draeger

Draeger Ltd [157747]The WillowsMark RoadHemel Hempstead, Hertfordshire HP2 7BWEnglandPhone: 44 (1442) 213542Fax: 44 (1442) 240327Internet: http://www.draeger.co.uk

Draeger Medical Inc [371341]3135 Quarry RdTelford PA 18969Phone: (215) 721-5400, (800) 437-2437Fax: (215) 723-5935E-mail: [email protected]: http://www.draegermedical.com




12/48

Draeger Southeast Asia Pte LtdMedical Div [354511]73 Science Park Drive #02-01/04Cintech 1SingaporeRepublic of Singapore

Phone: 65 8729278Fax: 65 7792165

Draegerwerk AG [139322]Moislinger Allee 53-55Postfach 1339D-23558 LuebeckGermanyPhone: 49 (451) 8820Fax: 49 (451) 8821654Internet: http://www.draeger.com

Hamilton

Hamilton Medical AG [138228]via NovaCH-7403 RhaezuensSwitzerlandPhone: 41 (81) 6606010Fax: 41 (81) 6606020E-mail: [email protected]: http://www.hamilton-medical.ch

Hamilton Medical Inc [105689]PO Box 30008Reno NV 89520-3008

Phone: (775) 858-3200, (800) 426-6331Fax: (775) 856-5621E-mail: [email protected]: http://www.hamilton-medical.com

Hamilton Medical Singapore [418184]Temasek Avenue 1#27-01 Millania TowerSingapore 039192Republic of SingaporePhone: 65 63569541Fax: 65 63531673Internet: http://www.hamilton-medical.com

Impact

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

Intermed

Intermed Equipamento Medico Hospitalar Ltda[174394]

Avenida Cupece 1786Cidade Ademar

Sao Paulo-SP 04366-000BrazilPhone: 55 (11) 56701303Fax: 55 (11) 55624862E-mail: [email protected]: http://www.intermed.com

Kimura

S Kimura Medical Instrument Co Ltd [152416]17-5 Yushima 2-chomeBunkyo-kuTokyo 113JapanPhone: 81 (3) 38144061Fax: 81 (3) 38145304E-mail: [email protected]: http://www.kimura-medical.co.jp

Maquet

Maquet Critical Care ABA Getinge Group Co [439169]Roentgenvaegen 2S-171 95 Solna

SwedenPhone: 46 (8) 7307300Fax: 46 (8) 985775E-mail: [email protected]: http://www.maquet.com/criticalcare

Maquet GmbH & Co KGA Getinge Group Co [305482]Kehler Strasse 31D-76437 RastattGermanyPhone: 49 (7222) 9320Fax: 49 (7222) 932828

E-mail: [email protected]: http://www.maquet.com

Maquet Inc [336117]1140 East Route 22Suite 202Bridgewater NJ 08807Phone: (888) 627-8383Fax: (908) 947-2301E-mail: [email protected]: http://www.maquet-inc.com




13/48

Newport

Newport Medical Instruments Europe [187402]18 Pasture RoadBarton-upon-Humber, South Humberside DN185HN

EnglandPhone: 44 (4682) 31311E-mail: [email protected]: http://www.ventilators.com

Newport Medical Instruments Inc [105093]PO Box 2600Newport Beach CA 92658Phone: (949) 642-3910, (800) 451-3111Fax: (949) 548-3091E-mail: [email protected]: http://www.ventilators.com

Pulmonetic Systems

Pulmonetic Systems Inc [366511]17400 Medina Rd Suite 100Minneapolis MN 55447Phone: (763) 398-8300, (866) 752-1438Fax: (763) 398-8400E-mail: [email protected]: http://www.pulmonetic.com

Saime

Saime SA [263810]21 25 rue de lEtainF-77176 Savigny-le-TempleFrancePhone: 33 (1) 64191111Fax: 33 (1) 64418130E-mail: [email protected]: http://www.saime.fr

Siare

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

Taema

TaemaSub LAir Liquide SA [151544]6 rue Georges Besse CE 80F-92182 Antony Cedex

FrancePhone: 33 (1) 40966600Fax: 33 (1) 40966700E-mail: [email protected]: http://www.taema.com

Tecme

Tecme SA [226196]Avenida Fuerza Aerea 46375010 Cordoba

Pcia de CordobaArgentinaPhone: 54 (351) 4651067Fax: 54 (351) 4650208E-mail: [email protected]

Tyco Healthcare Puritan Bennett

Puritan-Bennett CorpDiv Tyco Healthcare Group LP [101913]4280 Hacienda DrPleasanton CA 95488Phone: (925) 463-4000, (800) 635-5267Fax: (925) 463-4680Internet: http://www.puritanbennett.com

Tyco Healthcare Pte LtdDiv Tyco Healthcare Group LP [399028]26 Ang Mo Kio Industrial Park #04-01Singapore 569507Republic of SingaporePhone: 65 64820100Fax: 65 64820300E-mail: [email protected]

Internet: http://www.tycohealthcare.com

Tyco Healthcare UK LtdDiv Tyco Healthcare Group LP [398199]154 Fareham RoadGosport, Hampshire PO13 OASEnglandPhone: 44 (1329) 224000Fax: 44 (1329) 220213E-mail: [email protected]: http://www.tycohealthcare.uk




14/48

VersaMed

VersaMed Inc Indian Sub-Continent Office[449826]D-25 GF Pamposh EnclaveGK-1New Delhi 110048IndiaPhone: 91 (11) 26287418Fax: 91 (11) 26448836E-mail: [email protected]: http://www.versamed-China.com

VersaMed Medical Systems Inc [378254]2 Blue Hill PlazaPearl River NY 10965Phone: (845) 770-2840, (800) 475-9239Fax: (845) 770-2850E-mail: [email protected]: http://www.versamed.net

VersaMed Medical Systems Inc (Singapore)[449824]Block 518 #08-214Serangoon North Avenue 4Singapore 550518Republic of SingaporePhone: 65 62873489Fax: 65 62872489E-mail: [email protected]: http://www.versamed.com

VIASYS Healthcare

VIASYS Healthcare GmbH [416018]Leibnizstrasse 7D-97204 HoechbergGermanyPhone: 49 (931) 49720Fax: 49 (931) 4972423E-mail: [email protected]: http://www.viasyshealthcare.com

VIASYS Healthcare IncCritical Care Div [444110]1100 Bird Center DrPalm Springs CA 92262Phone: (760) 778-7200Fax: (760) 778-6355E-mail: [email protected]: http://www.viasyshc.com

About the chart specifications

The following terms are used in the chart:

I:E ratio: The ratio of inspiratory time to expiratorytime.

PEEP/CPAP, cm H2O: PEEP is positive end-expiratorypressure; CPAP is continuous positive airway pres-sure. Both are expressed in cm H2O.

Assist mode: The ventilator delivers breaths when itsenses the patients inspiratory efforts.

Control mode: The ventilator delivers breaths at cho-sen intervals.

IMV/SIMV: Intermittent mandatory ventilation/synchronized intermittent mandatory ventilation.

Abbreviations:

ANSI American National Standards Institute

APRV Airway pressure release ventilation

ARO After receipt of order

BGM Bird graphics monitor

BTPS Body temperature pressure saturation

CE mark Conformite Europeene mark

CEI Comitato Elettrotecnico Italiano

cETL Canadian ETL Testing Laboratories

CISPR Comite International Special des Pertur-bations Radioelectrique (International SpecialCommittee on Radio Interference)

CMV Controlled mechanical ventilation

CPAP Continuous positive airway pressure

CPU Central processing unit

CSA Canadian Standards Association

DIN Deutsches Institut fuer Normung

EL Electroluminescent

EN European Norm

FDA U.S. Food and Drug Administration

FiO2 Fraction of inspired oxygen

GLEM Groupement des Laboratoires dEssaisdes Materiels de Technique Medicale

I:E ratio Inspiratory:expiratory ratio

IEC International Electrotechnical Commission

ISO InternationalOrganizationfor Standardiza-tion

JIS Japanese Industrial Standards

JMMI Japanese Machine and Metals Institute

kPa Kilopascals




15/48

LCD Liquid crystal display

LED Light-emitting diode

MAP Mean airway pressure

MDD Medical Devices Directive

MIP Mean inspiratory pressure

MMV Mandatory minute volume

MV Minute volume (liters/minute, or L/min)

NFC National Fire Code

Ni-Cd Nickel-cadmium

Ni-MH Nickel-metal hydride

NRTL NationallyRecognizedTesting Laboratory

PC Personal computer

PCV Pressure-controlled ventilation

PEEP Positive end-expiratory pressure

PIP Peak inspiratory pressure

PRVC Pressure-regulated volume control

psig Pounds per square inch gauge

PSV Pressure-support ventilation

SEV Schweizerischer Electrotechnischer Verein

SIMV Synchronized intermittent mandatory

ventilationSLA Sealed lead-acid

SVGA Super Video Graphics Array

TFT Thin-film transistor

TUV Technischer Ueberwachungs Verein

TV Tidal volume

UL Underwriters Laboratories

UPS Uninterruptible power supply

VAPS Volume-assured pressure support

VCV Volume-controlled ventilation

VGA Video Graphics Array

WOBimp Imposed work of breathing

Note: The data in the charts derive from suppli-ers specifications and have not been verified throughindependent testing by ECRI or any other agency.Because test methods vary, different products specifi-cations arenotalways comparable. Moreover,productsand specifications are subject to frequent changes.ECRI is not responsible for the quality or validity ofthe information presented or for any adverse conse-quences of acting on such information.

When reading the charts, keep in mind that, unlessotherwise noted, the list price does not reflect supplierdiscounts. And although we try to indicate whichfeatures and characteristics are standard and whichare not, some may be optional, at additional cost.

For those models whose prices were supplied to usin currencies other than U.S. dollars, we have alsolisted the conversion to U.S. dollars to facilitate com-

parison among models. However, keep in mind that

exchange rates change often.

Need to know more?

For further information about the contents of thisProduct Comparison, contact the HPCS Hotline at +1(610) 825-6000, ext. 5265; +1 (610) 834-1275 (fax); [email protected] (e-mail).




16/48

Product Comparison Chart

MODEL ECRI-RECOMMENDED ECRI-RECOMMENDED ACOMA ACOMASPECIFICATIONS * SPECIFICATIONS *Basic IC Ventilator Mid/High IC ART-21EX ART-1000

Ventilator

WHERE MARKETED Not specified Not specified

FDA CLEARANCE Not specified Not specified

CE MARK (MDD) Not specified Not specified

CONTROLSTidal volume, mL 50-2,000 50-2,000 50-1,300 50-1,300Insp flow, L/min 3-180 3-180 5-65 5-65Insp press, cm H2O 0-80 5-60 0-70 5-70Respiratory rate,

breaths/min 6-120 6-120 6-40 6-40Insp time, sec 0-3 pause 0-3 pause 0.5-5 0.5-5 (SIMV)Exp time, sec 1-8 1-8 Not specified Not specifiedI:E ratio 1:4 to 4:1 1:4 to 4:1 1:0.3 to 1:3 1:0.3 to 1:3Insp hold/plateau 0-3 sec 0-3 sec 0-30% insp time 0-50% insp timeExpiratory hold 0-3 sec 0-3 sec Not specified Not specifiedFiO2, % 30-90 30-90 21-100 21-100Manual breath Yes Yes Yes No

PEEP/CPAP, cm H2O 0-45 0-45 0-20 0-20Pressure support,

cm H2O 0-45 0-45 Not specified Not specifiedNebulizer Optional Optional Yes YesTrigger mechanism Flow, pressure, both Flow, pressure, both Flow Flow, pressureBias/base flow

range, L/min 1-20 1-20 5 10-30Pressure slope/ramp

adjustment Yes/yes Yes/yes NA Not specifiedSigh Optional Optional Yes Yes100% O2 Not specified Not specified

OPERATING MODESAssist/control

Volume breaths Yes Yes Yes YesPressure breaths Yes Yes Yes Yes

SIMVVolume breaths Yes Yes Yes YesPressure breaths Optional Yes Yes YesPressure support Yes Yes Yes Yes

Spontaneous/CPAPPressure support Yes Yes Yes Yes

Apnea-backup vent Yes Yes Yes YesOthers User preference Combination modes None specified Pressure-limited CMV

(pressure & volume),responsive valve,bilevel/APRV

EQUIPMENT ALARMSGas supply failure Yes Yes Yes YesPower failure Yes Yes Yes YesVent inoperative Yes Yes Yes YesLow battery Yes Yes Yes Not specifiedSelf-diagnostics Valve leak, sensor Valve leak, sensor CPU error CPU error

failure failureOthers By user requirements By user requirements Flow rate, Flow detector con-

preset failure nection, apnea, flowrate, preset failure

Colons separate data on similar models of a device. This is the first of* These recommendations are the opinions of ECRI's technology experts. ECRI assumes no liability for decisions made based on three pages covering

this data. the above model(s).These specificationscontinue onto thenext two pages.




17/48



Ventilator

PATIENT ALARMS

O2 Yes Yes Yes YesLow minute volume Yes Yes Yes YesLow inspir pressure Yes Yes Yes YesHigh pressure Yes Yes Yes YesLoss of PEEP Optional Yes Yes YesApnea Yes Yes Yes YesHigh continuous

pressure/occlusion Yes Yes Not specified Not specifiedInverse I:E Yes Yes Not specified Not specifiedHigh respir rate Yes Yes Yes YesHigh minute vol Optional Yes Yes YesHigh PEEP Optional Yes Yes YesOthers None specified None specified

MONITORED PARAMETERSPressure

PIP Yes Yes Yes YesMAP Yes Yes Yes Yes

PEEP Yes Yes Yes Yes

VolumeTidal Yes Yes Yes YesMinute Yes Yes Yes YesSpontaneous minute Optional Yes Yes Yes

FiO2 Yes Yes Optional OptionalRespiratory rate Yes Yes Yes Not specifiedInspiratory time Yes Yes Yes YesExpiratory time Yes Yes Yes YesI:E Yes Yes Yes YesOthers Based on user Based on user None specified None specified

requirements requirements

INTERFACINGOutput ports Optional Optional No NoRemote alrm/display Optional Optional No NoAnalog output Optional Optional No OptionalReport generation

Display Required Required Not specified NoHard copy Required Required Not specified NoArchival disk Preferred Preferred Not specified NoNetwork Preferred Preferred Not specified No

DISPLAY TYPES User preference User preference LED LED

DATA DISPLAYED User customizable User customizable Not specified Not specified

PNEUMATIC POWERCompressor Optional Optional Optional Not necessaryCompressed gases O2, air O2, air Not specified O2

Pressure ranges 35-65 psi 35-65 psi 20 kPa 250 kPa

Colons separate data on similar models of a device. This is the second of* These recommendations are the opinions of ECRI's technology experts. ECRI assumes no liability for decisions made based on three pages covering

this data. the above model(s).These specificationscontinue onto thenext page.




18/48



Ventilator

LINE POWER, VAC Standard Standard 100-240 (as specif- 100-240 (as specif-

ied), 50/60 Hz ied), 50/60 HzCurrent, amps Not specified Not specifiedWatts 330 300

BATTERY Required Required Yes NoType (number) Any common type Any common type Not specified NAOperating time, hr 1 1 Not specified NARechargeable Not specified NARecharging time, hr Not specified NA

H x W x D, cm (in) 125 x 40 x 62 136.4 x 49.4 x 45(50 x 15.7 x 24.8) (53.7 x 19.5 x 17.7)

WEIGHT, kg (lb) 67 (148) 70 (154.3)

PURCHASE INFORMATIONList price Not specified $20,000

Warranty 1 year 1 year

ServiceFactory/on-site Not specified Not specifiedTraining Not specified Not specified3rd-party service Not specified Not specifiedParts availability Not specified Not specified

Delivery time, ARO Not specified Not specified

Year first sold Not specified Not specifiedNumber sold

USA/worldwide Not specified Not specifiedFiscal year Not specified Not specified

OTHER SPECIFICATIONS None specified. None specified.

Colons separate data on similar models of a device.* These recommendations are the opinions of ECRI's technology experts. ECRI assumes no liability for decisions made based on

this data.




19/48


MODEL BIO-MED DEVICES BIO-MED DEVICES DRAEGER DRAEGER

CV-3 CV-4 Evita 2 dura Evita 4

WHERE MARKETED Worldwide Worldwide Worldwide Worldwide

FDA CLEARANCE Yes Yes Yes Yes

CE MARK (MDD) Yes Yes Yes Yes

CONTROLSTidal volume, mL 5-2,500 5-2,500 3-2,000 w/NeoFlow 3-2,000 w/NeoFlowInsp flow, L/min 1-120 1-120 6-180 6-180Insp press, cm H2O 0-120 0-120 0-80 0-80Respiratory rate,

breaths/min 5-150 5-150 0-150 0-150Insp time, sec 0.1-3 0.1-3 0.1-30 0.1-30Exp time, sec 0.2-120 0.2-120 0.1-30 0.1-30I:E ratio 3:1 to 1:99 3:1 to 1:99 1:300 to 300:1 1:300 to 300:1Insp hold/plateau No 0-1/3 inspir time Yes YesExpiratory hold Not specified Not specified Yes YesFiO2, % 21-100 w/opt blender 21-100 w/opt blender 21-100 21-100Manual breath Yes Yes Yes Yes


cm H2O Not specified Not specified 0-80 0-80Nebulizer No Yes Yes YesTrigger mechanism Pressure Pressure Flow FlowBias/base flow

range, L/min Not specified Not specified Not specified Not specifiedPressure slope/ramp

adjustment Not specified Not specified Yes YesSigh Yes Yes Yes Yes100% O2 Not specified Not specified Yes Yes


Volume breaths Yes Yes Yes, AutoFlow Yes, AutoFlowPressure breaths Yes Yes Yes Yes

SIMVVolume breaths Yes Yes Yes YesPressure breaths Yes Yes Yes YesPressure support Yes Yes Yes Yes

Spontaneous/CPAPPressure support Yes Yes Yes Yes

Apnea-backup vent Yes Yes Yes YesOthers None specified SIMV with shift Optional independent Optional independent

delay lung ventilation * lung ventilation *

EQUIPMENT ALARMSGas supply failure Yes Yes Yes YesPower failure Yes Yes Yes YesVent inoperative Yes Yes Yes YesLow battery Yes Yes Yes YesSelf-diagnostics Yes Yes Yes Yes

Others None specified None specified Exhl valve, flow- Exhl valve, flow-sensor insertion, sensor insertion,leak, compliance leak, compl iance

Colons separate data on similar models of a device. This is the first of* Also APRV, MMV, AutoFlow, and PCV+, and automatic tube compensation for all patient ranges, including nCPAP. All modes have three pages covering

the option of noninvasive delivery. the above model(s).These specificationscontinue onto thenext two pages.




20/48




PATIENT ALARMS

O2 Yes Yes Yes YesLow minute volume Yes Yes Yes YesLow inspir pressure Yes Yes Yes YesHigh pressure Yes Yes Yes YesLoss of PEEP Yes Yes Yes YesApnea Yes Yes Yes YesHigh continuous

pressure/occlusion Not specified Not specified Yes YesInverse I:E Yes Yes Yes YesHigh respir rate Yes Yes Yes YesHigh minute vol Yes Yes Yes YesHigh PEEP Yes Yes Yes YesOthers None specified None specified High tidal volume High tidal volume




VolumeTidal Yes Yes Yes YesMinute Yes Yes Yes YesSpontaneous minute Yes Yes Yes Yes

FiO2 Yes Yes Yes YesRespiratory rate No Optional Yes YesInspiratory time Yes Yes Yes YesExpiratory time Yes Yes Yes YesI:E Yes Yes Yes YesOthers None specified None specified Optional occlusion Optional occlusion

pressure, NIF, RSBi, pressure, NIF, RSBi,capnogram * capnogram *

INTERFACINGOutput ports RS232 RS232 RS232, analog RS232, analogRemote alrm/display Not specified Optional Optional OptionalAnalog output Not specified No Yes YesReport generation

Display Not specified Yes Via EvitaLink Via EvitaLinkHard copy Not specified Optional Via EvitaLink Via EvitaLinkArchival disk Not specified Optional Via EvitaLink Via EvitaLinkNetwork Not specified Optional Via EvitaLink Via EvitaLink

DISPLAY TYPES LCD with backlit LCD with backlit TFT color screen TFT color screentouchscreen touchscreen

DATA DISPLAYED Not specified Not specified Numbers, waveforms, Numbers, waveforms,loops, and trends loops, and t rends

PNEUMATIC POWERCompressor Available Available Optional OptionalCompressed gases O2, air O2, air O2, air O2, air

Pressure ranges 44-66 psig 44-66 psig 3-6 bar, 45-90 psi 3-6 bar, 45-90 psi

Colons separate data on similar models of a device. This is the second of* Also new sensor, no calibration data, remote fault, and transducer fault. three pages covering

the above model(s).These specificationscontinue onto thenext page.




21/48




LINE POWER, VAC 110/220 110/220 100-127/220-240 100-127/220-240

Current, amps Not specified Not specified 1.3(230V), 3.2(100V) 1.3(230V), 3.2(100V)Watts Not specified Not specified 125 125

BATTERY Yes Yes Optional OptionalType (number) Not specified Not specified Internal, 2 external Internal, 2 externalOperating time, hr 15 15 2 2Rechargeable Not specified Not specified Yes YesRecharging time, hr Not specified Not specified Not specified Not specified

H x W x D, cm (in) 27.9 x 24.8 x 13.7 27.9 x 24.8 x 13.7 53 x 29 x 45 (20.9 x 53 x 29 x 45 (20.9 x(11 x 9.8 x 5.4) (11 x 9.8 x 5.4) 11.4 x 17.7); 58 x 11.4 x 17.7); 58 x

131.5 x 66 (22.8 x 133.5 x 66 (22.8 x51.8 x 26) w/trolley 52.5 x 26) w/trolley

WEIGHT, kg (lb) 4.1 (9) 4.1 (9) 27 (59.5); 69 (152) 27 (59.5); 69 (152)w/trolley & cabinet w/trolley & cabinet

PURCHASE INFORMATIONList price Not specified Not specified $25,550 $31,130

Warranty 1 year 1 year 1 year 1 year

ServiceFactory/on-site Yes/yes Yes/yes Yes/yes Yes/yesTraining Yes Yes Yes Yes3rd-party service Not specified No Yes YesParts availability To customers, others To customers, others Yes Yes

Delivery time, ARO Not specified Not specified 4-6 weeks 4-6 weeks

Year first sold 1997 1995 1997 1996Number sold

USA/worldwide Not specified Not specified Not specified Not specifiedFiscal year October to September October to September January to December January to December

OTHER SPECIFICATIONS None specified. Auto patient- All gas measurements Evita 2 platformcompliance calcu- under BTPS condi- plus touch-lations; auto alarm tions; single rotary screen, ideal bodysettings; user help knob parameter weight setting, andscreens; foreign- adjustment; options cursor in displayedlanguage menus; and upgrades via graphics.12-30 V input software and/or

jack for transport; hardware; tubinginfant menu with system complianceinsp time and compensated; openconstant f low; opt breathing system inair entrainment for all modes and55-60% O2 patient ranges;concentration. optional SBCO2

(single-breath CO2)and SpO2. Meetsrequirements of IEC60601.

Colons separate data on similar models of a device.




22/48


MODEL DRAEGER HAMILTON HAMILTON IMPACT

Evita XL GALILEO RAPHAEL Uni-Vent 754

WHERE MARKETED Worldwide Worldwide Worldwide Worldwide

FDA CLEARANCE Yes Yes Yes Yes

CE MARK (MDD) Yes Yes Yes Yes

CONTROLSTidal volume, mL 3-2,000 w/NeoFlow 10-2,000 50-2,000 0-1,000Insp flow, L/min 6-180 1-180 0-180 0-60Insp press, cm H2O 0-95 0-100 0-50 above PEEP/CPAP 0-100Respiratory rate,

breaths/min 0-150 1-120 0-80 1-150Insp time, sec 0.1-30 0.1-9 0.1-3.2 0.1-3Exp time, sec 0.1-30 20-90% cycle time 20-90% cycle time NAI:E ratio 1:300 to 300:1 1:9 to 4:1 1:9 to 4:1 1:1 to 1:600Insp hold/plateau Yes 0-70% cycle time 0-70% cycle time 100% insp timeExpiratory hold Yes 10 sec max Not specified Not specifiedFiO2, % 21-100 21-100 21-100 21-100Manual breath Yes Yes Yes Yes


cm H2O 0-80 0-100 0-50 above PEEP/CPAP Not specifiedNebulizer Yes Yes Yes NoTrigger mechanism Flow Flow and pressure Flow PressureBias/base flow

range, L/min Not specified Automatic Automatic NAPressure slope/ramp

adjustment Yes 0.25-200 msec Auto set YesSigh Yes Yes Yes Yes100% O2 Yes Yes Yes Not specified


Volume breaths Yes, AutoFlow Yes Yes YesPressure breaths Yes Yes Yes No

SIMVVolume breaths Yes Yes Yes YesPressure breaths Yes Yes Yes YesPressure support Yes Yes Yes Not specified

Spontaneous/CPAPPressure support Yes Yes Yes No

Apnea-backup vent Yes Yes Yes YesOthers Optional independent AVtS, DuoPAP+, APRV, DuoPAP, None specified

lung ventilation * DuoPAP, NIV APV DuoPAP+(A/C and SIMV)

EQUIPMENT ALARMSGas supply failure Yes Yes Yes YesPower failure Yes Yes Yes YesVent inoperative Yes Yes Yes YesLow battery Yes Yes Yes YesSelf-diagnostics Yes Yes Yes Sensor failure, CPU

Others Exhl valve, flow- Technical faults Technical faults Low batt, TV,sensor insertion, valve leakleak, compliance

Colons separate data on similar models of a device. This is the first of* Also APRV, MMV, AutoFlow, and PCV+, and automatic tube compensation for all patient ranges, including nCPAP. All modes have three pages covering

the option of noninvasive delivery. the above model(s).These specificationscontinue onto thenext two pages.




23/48




PATIENT ALARMS

O2 Yes Yes Yes YesLow minute volume Yes Yes Yes YesLow inspir pressure Yes Yes Not specified YesHigh pressure Yes Yes Yes YesLoss of PEEP Yes Yes Yes YesApnea Yes Yes Yes YesHigh continuous

pressure/occlusion Yes Yes Yes YesInverse I:E Yes Not specified Not specified YesHigh respir rate Yes Yes Yes YesHigh minute vol Yes Yes Yes YesHigh PEEP Yes Not specified Not specified Not specifiedOthers High tidal volume Disconnection Disconnection None specified


PIP Yes Yes Yes YesMAP Yes Yes Yes Not specified


VolumeTidal Yes Yes Yes YesMinute Yes Yes Yes YesSpontaneous minute Yes Yes Yes Not specified

FiO2 Yes Digital Digital YesRespiratory rate Yes Yes Yes YesInspiratory time Yes Yes Yes YesExpiratory time Yes Yes Yes YesI:E Yes Yes Yes YesOthers Optional occlusion Insp/exp peak flow, Insp peak flow, None specified

pressure, NIF, RSBi, compliance, insp/exp compliance, expcapnogram * resistance, time resistance

constants, patienttrigger, air trap-ping, aux pressure

INTERFACINGOutput ports RS232, analog RS232C RS232C RS232Remote alrm/display Optional Yes Yes NoAnalog output Yes Yes Yes NoReport generation

Display Via EvitaLink Optional (LEONARDO) LEONARDO NoHard copy Via EvitaLink No No NoArchival disk Via EvitaLink No No NoNetwork Via EvitaLink Not specified Not specified No

DISPLAY TYPES TFT color screen Color screen, LCD, Color screen, LCD, LED, LCDTFT TFT

DATA DISPLAYED Numbers, waveforms, Real-time graphics, Real-time graphics, Numbers, graphics,loops, trends, and numbers, waveforms, loops, trends waveforms, alarmsshort trends loops, trends

PNEUMATIC POWERCompressor Optional Optional Optional YesCompressed gases O2, air O2, air; optional NO O2, air O2

Pressure ranges 3-6 bar, 45-90 psi 30-85 psi 29-86 psi 40-80 psi

Colons separate data on similar models of a device. This is the second of* Also new sensor, no calibration data, remote fault, and transducer fault. three pages covering

the above model(s).These specificationscontinue onto thenext page.




24/48




LINE POWER, VAC 100-127/220-240 100-240 100-240 95-265 autosensing

Current, amps 1.3(230V), 3.2(100V) 2.3 (100V), 1 (240V) 0.7 @ 120 VAC 5Watts 125 230 max 40 VA 60

BATTERY Optional Yes Yes YesType (number) Internal, 2 external Sealed lead-acid Internal Sealed lead-acidOperating time, hr 2 1 1 Not specifiedRechargeable Yes Yes Yes Not specifiedRecharging time, hr Not specified 6 6 Not specified

H x W x D, cm (in) 53 x 29 x 45 (20.9 x 40 x 62 x 154 23.1 x 53 x 35 29.2 x 23.5 x 12.411.4 x 17.7); 58 x (15.7 x 24.5 x 61) (9.1 x 20.9 x 13.8) (11.5 x 9.3 x 4.9)133.5 x 66 (22.8 x with standard without trolley52.5 x 26) w/trolley trolley

WEIGHT, kg (lb) 27 (59.5); 69 (152) 44 (97) 16.8 (37) 5.8 (12.8)w/trolley & cabinet without trolley

PURCHASE INFORMATIONList price $36,230 $29,820 $17,820 $8,495

Warranty 1 year 1 year, parts and 1 year, parts and 1 yearlabor labor

ServiceFactory/on-site Yes/yes Yes/yes Yes/yes NoTraining Yes Yes Yes Yes3rd-party service Yes Yes Yes NoParts availability Yes Yes Yes To customer

Delivery time, ARO 4-6 weeks 45-60 days 45-60 days 2 weeks

Year first sold 2002 1998 2003 1997Number sold

USA/worldwide Not specified Not specified Not specified Not specifiedFiscal year January to December December to November December to November January to December

OTHER SPECIFICATIONS Evita 4 platform Integral battery Meets requirements Includes built-inplus screen backup; 10-70% of ANSI Z79.10-1979/ air/oxygen mixer andcustomization (vent expiratory trigger Z797-1976, CSA, compressor; altitudecheck sheet, wave- sensitivity; insp DIN 13254, GLEM, and PEEP

forms, displayed time max; oxygen IEC 60601 and compensation;values), multiple analyzer; TRC; P/V 62D/60601, ISO automatic backlight-graphic capabilities tool; ventilation 121/5359/5369/7767, ing of LCD; pressure(short trends, up to analyzer window; JMMI, NFC 74-350, waveform; internal6 loops, combined operating modes SEV, and TUV. backup ventilator.cursor for simul- include AVtS, APV,taneous loop and CPAP, NIV, andwave analysis), and spontaneous. Meetsonline information requirements offor modes & alarms; ANSI Z79.10-1979/lung protection Z797-1976, CSA,package includes DIN 13254, GLEM,slow flow inf lection IEC 60601 andmaneuver; lung 62D/60601, ISOrecruitment trending 121/5359/5369/7767,and direct link for JMMI, NFC 74-350,pressure changes in SEV, and TUV.pressure control.

Colons separate data on similar models of a device.




25/48


MODEL INTERMED INTERMED KIMURA KIMURAFAILED TO RESPOND * FAILED TO RESPOND *

INTER 5 PLUS/GMX INTER PLUS KV-3N KV-5VAPS/GMX

WHERE MARKETED Worldwide Worldwide Asia, Middle East, Asia, Middle East,

South America, South America,others others

FDA CLEARANCE No No No No

CE MARK (MDD) Yes Yes No No

CONTROLSTidal volume, mL 10-2,000 10-2,000 30-3,500 50-3,500Insp flow, L/min 2-150 2-150 10-70 10-70Insp press, cm H2O 0-120 0-120 5-100 0-100Respiratory rate,

breaths/min 0-180 0-180 2-60 in 24 steps 2-60Insp time, sec 0.1-15 0.1-15 0.2-3 in 24 steps 0.3-3Exp time, sec 0.1 minimum 0.1 minimum Not specified Not specifiedI:E ratio 1:99 to 9.9:1 1:99 to 9.9:1 1:0.5 to 1:149 Not specifiedInsp hold/plateau Manual/50% insp time Manual/50% insp time Not specified PlateauExpiratory hold 15 sec maximum 15 sec maximum Not specified Not specifiedFiO2, % 21-100 21-100 21-100 21-100Manual breath Yes Yes Not specified Not specified


cm H2O 0-80 0-80 Not specified Not specifiedNebulizer Yes Yes Yes YesTrigger mechanism Pressure, flow Pressure, flow Not specified Not specifiedBias/base flow

range, L/min 0-40 0-40 0-40 Not specifiedPressure slope/ramp

adjustment No No Not specified Not specifiedSigh Yes Yes Yes Yes100% O2 No No Not specified Not specified


Volume breaths Yes Yes No NoPressure breaths Yes Yes No No

SIMVVolume breaths Yes Yes Yes YesPressure breaths Yes Yes Yes YesPressure support Yes Yes Not specified Not specified

Spontaneous/CPAPPressure support Yes Yes No Yes

Apnea-backup vent Yes Yes No YesOthers TGI, constant and TGI, constant and None specified None specified

decelerating wave decelerating waveflow flow

EQUIPMENT ALARMSGas supply failure Yes Yes Yes YesPower failure Yes Yes Yes YesVent inoperative Yes Yes Not specified Not specifiedLow battery Yes Yes Not specified Not specifiedSelf-diagnostics Not specified Not specified Not specified Not specified

Others None specified None specified Electrical failure Electrical failure

Colons separate data on similar models of a device. This is the first of* Specifications current as of June 2002. three pages covering

the above model(s).These specificationscontinue onto thenext two pages.




26/48


MODEL INTERMED INTERMED KIMURA KIMURAFAILED TO RESPOND * FAILED TO RESPOND *

INTER 5 PLUS/GMX INTER PLUS KV-3N KV-5VAPS/GMX

PATIENT ALARMS

O2 Yes Yes Not specified Not specifiedLow minute volume Yes Yes Not specified Not specifiedLow inspir pressure Yes Yes Not specified Not specifiedHigh pressure Yes Yes Not specified Not specifiedLoss of PEEP No No Not specified Not specifiedApnea Yes Yes Not specified Not specifiedHigh continuous

pressure/occlusion Not specified Not specified Not specified Not specifiedInverse I:E No No Not specified Not specifiedHigh respir rate No No Not specified Not specifiedHigh minute vol No No Not specified Not specifiedHigh PEEP Yes Yes Not specified Not specifiedOthers None specified None specified None specified None specified




VolumeTidal Yes Yes Not specified Not specifiedMinute Yes Yes Not specified Not specifiedSpontaneous minute Not specified Not specified Not specified Not specified

FiO2 Yes Yes Yes Not specifiedRespiratory rate Yes Yes Not specified Not specifiedInspiratory time Yes Yes Not specified Not specifiedExpiratory time No No Not specified Not specifiedI:E Yes Yes Not specified YesOthers None specified None specified None specified Inverse I:E ratio

INTERFACINGOutput ports RS232 RS232 Not specified NoRemote alrm/display No No Not specified NAAnalog output Yes Yes Not specified NAReport generation

Display Not specified Not specified Not specified NAHard copy Not specified Not specified Not specified NAArchival disk Not specified Not specified Not specified NANetwork Not specified Not specified Not specified NA

DISPLAY TYPES VGA 320 x 240, 5.7" VGA 320 x 240, 5.7" Digital LEDs Digital LEDsLED (red/yellow/grn) LED (red/yellow/grn)

DATA DISPLAYED Numbers, text, Numbers, text, Not specified Not specifiedgraphics, loops, graphics, loops,trends trends

PNEUMATIC POWERCompressor Optional INTER 3500 Optional INTER 3500 Optional OptionalCompressed gases O2, air O2, air O2, air O2, air

Pressure ranges 2.5-5 kg/cm2 2.5-5 kg/cm2 3.5-4.5 kg/cm2 3.5-4.5 kg/cm2

Colons separate data on similar models of a device. This is the second of* Specifications current as of

Ventilators, Intensive Care

Documents

Transcript of Ventilators, Intensive Care