Multiple Medical Gas Monitors, Respired_Anesthetic_090313084140

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Multiple Medical Gas Monitors,Respired/Anesthetic

This Product Comparison covers the following device term and product code as listed in ECRI Institute’s Universal

Medical Device Nomenclature System™ (UMDNS™):

Monitors, Bedside, Respiration/Anesthetic Gas [17-445]

Scope of this Product Comparison

This Product Comparison covers stand-alone and modular multiple medical gas monitors (MMGMs) that can

determine concentrations of anesthetic and respiratory gases (oxygen [O2], nitrous oxide [N2O], carbon dioxide

[CO2], and halogenated agents) in the patient breathing circuit during anesthesia. Centralized mass-spectrometer-

based respiratory/anesthetic gas monitors that are hardwired to patient rooms or operating rooms (ORs) are

excluded. For more information on related monitors, see the Product Comparison titled Carbon Dioxide Monitors,

Exhaled Gas.

These devices are also called: multigas monitors.

Purpose MMGMs continuously sample and measure inspired and expired (end-tidal)

concentrations of respiratory and anesthetic gases during and immediately

following anesthetic administration. An overdose of anesthetic agent and/or too

little O2 can lead to brain damage and death, while an underdose of agent will

result in insufficient anesthesia.

Some deaths related to anesthesia use might be preventable with adequate respired

and anesthetic gas monitoring in the OR. During general anesthesia, the patient’s

physiologic status must be continuously assessed and trends and sudden

changes quickly identified. Gas monitoring provides the anesthetist with

information about the patient’s physiologic status, verifies that the appropriate

levels of delivered gases are administered, and warns of equipment failures or abnormalities in the gas delivery system. MMGMs display inspired/expired gas

concentrations and sound alarms to alert clinical personnel when the

concentrations of measured gases and the physiologic parameters fall outside set

limits. In most units, the gases are automatically identified and quantified, although

some MMGMs require that the user select the halogenated agent being used or

that the monitor be equipped with a special option to identify the halogenated

agent.

5200 Butler Pike, Plymouth Meeting, PA 19462-1298, USA Tel +1 (610) 825-6000 Fax +1 (610) 834-1275 Web www.ecri.org E-mail [email protected]

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Principles of Operation

Most MMGMs are sidestream monitors, which aspirate samples from the breathing circuit through narrow-diameter

tubing that is usually made of polyvinyl chloride (PVC). Nafion sampling lines that can connect to any monitor are

also available from most monitor manufacturers or from independent sources. (Nafion allows moisture to pass

through the sampling line and into the atmosphere. Water vapor can affect infrared [IR] spectrometric

measurements.) Some manufacturers use a water trap and/or filter to remove condensation from the sample, thereby

reducing water vapor before the gas sample reaches the analysis chamber. Gas samples are aspirated into the

monitor at either an adjustable or a fixed flow rate, typically from 50 to 250 mL/min. Lower rates minimize the amount

of gas removed from the breathing circuit and therefore from the patient’s tidal volume; however, in some MMGMs,

low sampling flow rates can increase the response time (rise time) and reduce the accuracy of measurements. Most

monitors eliminate the exhaust gas through a port on the rear of the unit that can be attached to a scavenging

system or to the patient’s breathing circuit (in closed-loop

systems).

Because they measure chemically diverse substances, MMGMs

commonly combine more than one analytical method. Most

MMGMs measure concentrations of halogenated anesthetic

agents, CO2, and N2O using nondispersive IR absorption

technology; either an electrochemical (galvanic) cell or a

paramagnetic sensor is typically used to measure respired O2

concentration. Some MMGMs use a piezoelectric method to

measure anesthetic agent concentration.

Dual-chamber nondispersive IR spectrometers pass IR energy

from an incandescent filament through the sample chamber and

an identical but air-filled reference chamber. Each gas absorbs

light at several wavelengths, but only one absorption wavelength

is selected for each gas to determine the gas concentration. The

light is filtered after it passes through the chambers, and only the wavelength selected for each gas is transmitted to

the detector. The light absorption in the analysis chamber is proportional to the partial pressure of the gas. When IR

spectrometry is used to determine halogenated agent concentration, the anesthetics are usually analyzed along a

separate, longer optical path within the MMGM that can accommodate the weaker signal generated by the

halogenated anesthetics.

Monitors that can identify as well as quantify halogenated agents typically use a chamber separate from the one

used for measuring CO2 and N2O, measure absorption in the 7 to 14 µm range, and use single-channel,

multiwavelength IR filter photometers. Each of several filters (one for each anesthetic agent and one to provide a

baseline for comparison) transmits a specific wavelength of IR light, and each gas absorbs the light differently in the

selected wavelength bands.

Monitors that require the user to select the delivered agent to be measured use a wavelength range around 3.3 µm—

the peak wavelength at which the hydrogen-carbon bond absorbs light. Such MMGMs therefore cannot distinguish

among the various halogenated agents or other molecules that contain carbon-hydrogen bonds.

The piezoelectric method measures the concentration of a selected halogenated agent. The sample is pumpedthrough a chamber containing two crystals: a reference crystal and a second crystal that has been coated with an

organophilic compound to adsorb the anesthetic gas. The resulting increase in mass changes the coated crystal’s

resonant frequency in direct proportion to the concentration of anesthetic gas in the sample, thereby generating a

voltage that is displayed as the percentage of vapor. The reference crystal and microprocessor compensate for the

effects of temperature and of atmospheric pressure variations.

In the galvanic cell, O2 diffuses through a semipermeable membrane, reaches a reducing electrode, and is carried by

a reaction product to the other (reference) electrode, where it frees electrons. The rate at which O2 diffuses into the

Multiple Medical Gas Monitors, Respired/Anesthetic

of 9©2013 ECRI Institute. All Rights Reserved.



cell and generates voltage is directly proportional to the partial pressure of O2 diffusing through the membrane.

Several factors affect the output and lifetime of the cells. The temperature of the O2 affects the rate of its diffusion

through the membrane and therefore the output of the cell; a thermistor incorporated into the cell compensates for

temperature changes. During its life, the electrode loses water—some diffuses out as O2 enters the cell, and some is

consumed through oxidation—and it eventually requires replacement.

The design of paramagnetic sensors for measuring O2 concentration is based on the high degree of susceptibility of

O2 (compared to other gases) to magnetic forces. The sensor consists of a symmetric cell with identical chambers for

the sample and the reference gas (air) joined at an interface by a differential pressure transducer or microphone. The

sample and reference gases are pumped through these chambers to a common outlet. A strong magnetic field

surrounding the region just before the gases come together acts on the O2 molecules to generate a pressure

difference between the two sides of the cell, causing the transducer to produce a voltage proportional to the O2

concentration.

The user typically calibrates or verifies calibration of the MMGM

with a standard gas mixture from an integral or external gas

cylinder. Some units, however, provide an automatic-calibration

feature.

MMGMs are microprocessor controlled and have user-

adjustable alarms that typically include factory-preset default

alarms and/or alarm-set programs for both high and low

concentrations of the gases measured. Some monitors also have

alarms for system malfunctions such as disconnection (air leaks

can often be identified from trending of O2 and CO2), occlusion,

apnea, or inadvertent rebreathing. MMGMs typically have a

method for temporarily silencing audible alarms for low O2, high

N2O, and high agent concentrations, while other, less critical

audible alarms can be permanently silenced.

MMGMs typically display waveforms and trends. They have integral display capability and are also commonly

equipped with output jacks to interface with computerized anesthesia record-keeping systems or with additional

analog and/or digital display units, such as chart recorders and printers.

Many units provide a graphic display of breath-by-breath concentrations and a hard copy of trends of gas

concentrations from the beginning to the end of the anesthesia event.

Reported Problems

The accumulation of water-vapor condensation or other materials in the sampling chamber can interfere with the

accuracy of MMGMs. Some monitors circumvent this problem by trapping condensate before it reaches the

chamber, while others use special tubing (Nafion) and hydrophobic filters to prevent water vapor from affecting

monitor performance; however, some manufacturers still recommend periodically cleaning the chamber, particularly

to prevent the accumulation of secretions or other foreign matter.

The presence of nitrogen (N2) in the inspired gases indicates that air is being aspirated into the breathing circuit,

thereby diluting the delivered gas concentration. Although most MMGMs do not monitor N2 concentration, such

leaks can often be identified from changing O2 and CO2 trends.

For MMGMs that cannot identify halogenated agents, the user must set the agent selection control according to the

halogenated anesthetic being used. Clinical personnel must be relied on to fill the vaporizers with the proper agent (a

keyed filling system will help prevent errors) and to connect the breathing circuit correctly to preclude accidental

use of the wrong or multiple anesthetics.


of 9 ©2013 ECRI Institute. All Rights Reserved.



The presence of alcohol or other organic vapor in the room, in a sample line, or in a patient’s breath can cause

inaccurate concentration readings on monitors that cannot distinguish these compounds from anesthetic agents.

MMGMs that both identify and quantify halogenated agents can eliminate interference from these compounds

because these monitors measure concentrations of halogenated agents at a wavelength where organic vapors do

not have a peak in the IR absorption spectrum.

Purchase Considerations

Included in the accompanying comparison chart are ECRI Institute’s recommendations for minimum performance

requirements for MMGMs.

The MMGM should continuously sample and measure inspired and expired concentrations of respiratory and

anesthetic gases during and immediately following anesthetic administration. The device may also include

monitoring of other variables such as oxygen saturation (SpO2), airway pressure, and volume monitoring.

The MMGM should display inspired and expired gas concentrations of CO2 and halogenated agent, inspired (or

mean) concentrations of O2 and N2O, and respiration rate.

Monitors should accurately measure gas concentration over the range that is encountered clinically and should

compensate for the interference effects between gas constituents. The range that a monitor should be able to

measure and the accuracy that it should achieve for each of the analyzed gases should be as follows:

0-6% halothane with an accuracy of 0.25 volume %.

0-6% enflurane with an accuracy of 0.25 volume %.

0-6% isoflurane with an accuracy of 0.25 volume %.

0-20% desflurane with an accuracy of 0.25 volume %.

0-10% sevoflurane with an accuracy of 0.25 volume %.

0-80% nitrous oxide with an accuracy of 10% of reading or 5 volume %, whichever is greater.

0-10% carbon dioxide with an accuracy of 10% of reading or 0.4 volume %, whichever is greater.

0-100% oxygen with an accuracy of 5% of reading or 2 volume %, whichever is greater.

Interference with measurements caused by the presence of water vapor, aspirated fluid, or pressure in the breathing

circuit should be eliminated or automatically compensated for by the MMGM.

The MMGM should remain zeroed and calibrated for at least six months.

Measurements should remain accurate over commonly used ventilation rates (i.e., 25 breaths/min for adults and up

to 60 breaths/min if the monitor is intended for neonatal or pediatric applications).

Alarm limits should be easy to review and set. The anesthetist should be able to view all alarm limits and gas

concentration displays simultaneously while reviewing and setting alarm limits. Alarms should be available for all

parameters that the MMGM monitors. The unit should alarm to indicate an occluded sampling line or a system

failure.

For safe, effective monitoring, units should meet several minimum critical alarm criteria:

The apnea alarm (associated with CO2 monitoring) and the low O2 alarm limit are critical in all situations and

should be impossible to disable while a patient is connected.

For low O2, it should not be possible to lower alarm limits to values that are not clinically useful (minimum

settings of 18%).

Monitors should allow flexibility in setting alarm limits and help minimize the use of inappropriate settings,

and the alarm limits should be easy to review on a single screen.

If the displayed CO2 concentration is changed between mm Hg and percent CO2, the actual alarm-limit setting

should not be altered, and preferably, the alarm limit will be converted into the new units. It should not be possible





to indefinitely silence the apnea alarm.

Agent monitoring should activate automatically when the unit is turned on. It is acceptable, however, for the unit to

require that agent be selected before monitoring begins, provided that the unit warns the user when agent is

detected but has not been selected.

The MMGM should display the CO2 waveform. It is preferable that the unit allow the user to select at least two

additional graphical displays (e.g., waveforms and trends).

Exhaust gas from the MMGM must be returned to the patient’s breathing circuit or scavenged. Performance should

not be affected by attachment to a scavenger. When gas is to be scavenged, an easy-to-access port to which the

sampling tube cannot be connected should be provided with the monitor. Manufacturers should provide tubing (of

a smaller diameter than the breathing circuit) with the appropriate fittings to connect the exhaust port to the

expiratory breathing circuit (22 mm tee) or a scavenger (19 mm tee).

Other considerations

MMGMs are produced as either a configured unit or a modular part of a physiologic monitoring system. A facility

should consider the status of its present physiologic monitoring system before purchasing an MMGM. A modular

MMGM may allow all information and alarms to be integrated into one display. MMGMs can also be integrated intoanesthesia delivery units.

The variety of MMGM configurations available permits a facility to add modules to expand the capabilities of its

monitoring equipment. For example, if a hospital has pulse oximeters, it can purchase units without the pulse

oximeter option. If a facility is planning to replace its current anesthetic delivery equipment, it may want to consider

an anesthesia system with optional modules for combined CO2, N2O, and agent monitoring and/or for pulse

oximetry.

To achieve the degree of accuracy and performance reliability necessary for anesthetic monitoring, MMGMs require

careful maintenance by qualified biomedical engineering personnel. Users may want to check the availability of

service and the repair turnaround time before selecting multigas monitors for their facilities.

Environmental considerations

As a result of increasing concerns over the environment and the conservation of resources, many manufacturers

have adopted green shipping and production methods, as well as features that improve the energy efficiency of their

products or make them more recyclable. In addition, healthcare facilities and device manufacturers have begun to

adopt green initiatives that promote building designs and work practices that reduce waste and encourage the use

of recycled materials.

Facilities should look for manufacturers who offer take-back programs on system equipment. If a supplier does not

offer such an arrangement, the facility must absorb the costs of disposing the system according to local

environmental protection laws when it is replaced.

Stage of DevelopmentIR analyzers have been used for many years to identify and assay compounds for research applications. More

recently, they have been adapted for respiratory monitoring of CO2, N2O, and halogenated agents. Some

instruments are now designed to both identify and quantify specific agents.

A monitor using IR photoacoustic technology has been developed that can quantify all commonly

respired/anesthetic gases except N2 and water vapor; like some other MMGMs, it also has a built-in pulse oximeter.

Alarms alert OR personnel in the event of gas concentration delivery outside the set limits.





In addition, some monitors are made from nonferrous materials and are marketed for use during magnetic resonance

imaging procedures.

Bibliography

Ansermino JM, Daniels JP, Hewgill RT, et al. An evaluation of a novel software tool for detecting changes in physiological monitoring. Anesth Analg 2009 Mar;108(3):873-80.

Berggren M, Hosseini N, Nilsson K, et al. Improved response time with a new miniaturised main-stream multigas

monitor. J Clin Monit Comput 2009 Dec;23(6):355-61.

Daniels JP, Ansermino JM. Introduction of new monitors into clinical anesthesia. Curr Opin Anaesthesiol 2009

Dec;22(6):775-81.

Garg R. Misleading display of haemodynamic and respiratory parameters: frozen monitor. Singapore Med J 2009

Sep;50(9):921.

Glen J. Use of audio signals derived from electroencephalographic recordings as a novel ‘depth of anaesthesia’

monitor. Med Hypotheses 2010 Aug 19.

Heijbel H, Ostblom J, Brattwall M, et al. Anaesthetic gas monitoring comparison between two side-stream monitors.

Clin Monit Comput 2010 Apr;24(2):169-72.

Liu D, Jenkins SA, Sanderson PM. Patient monitoring with head-mounted displays. Curr Opin Anaesthesiol 2009

Dec;22(6):796-803.

Melo MF, Leone, BJ. Introduction of new monitors into clinical anesthesia. Anesth Analg 2008 Sep;107(3):749-50.

Last updated February 2011

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Manufacturer GE Healthcare USACardiocap 5<1>

Draeger Medical IncVamos Plus

Philips (Deutschland) GmbHIntelliVue G1 Anesthesia GasMonitoring

Spacelabs Healthcare IncUltraview SL 91518 Multigas Analyzer

WHERE MARKETED Worldwide Worldwide Worldwide Worldwide

FDA CLEARANCE Yes Yes Yes Yes

CE MARK (MDD) Yes Yes Yes Yes

MODULAR/CONFIGURED Configured Configured with options Modular with IntelliVue monitors Modular

OPERATING PRINCIPLES IR for CO2, N2O, agents;paramagnetic for O2

NDIR NDIR technology (CO2, N2O, 5agents), paramagnetic (O2)

NDIR (CO2, N2O, anestheticagents), microfuel fast chemical

O2 cell for oxygenSAMPLING FLOW, mL/min 200, ±20 200 200 200 ± 20

AUTOMATIC ANESTHETICAGENT ID

Yes Yes Manual selection of agent usedfrom all 5 agents available;automatic identification of all 5agents

Automatic or manual

GAS CONCENTRATIONRANGE, volume %

Halothane 0-6 0-8.5 0-8.5 0-6

Enflurane 0-6 0-10 0-10 0-6

Isoflurane 0-6 0-8.5 0-8.5 0-6

Desflurane 0-20 0-22 0-20 0-20

Sevoflurane 0-8 0-10 0-10 0-8

N2O 0-100 0-99 0-100 0-100

CO2 0-15 (113 mm Hg) 0-10 0-76 mm Hg 0-15 (0-113 mm Hg)

O2 0-100 NA 5-100 0-100

RISE TIME, msec

Agent <400 <500 <500 <400

N2O <450 <500 <500 <450

CO2 <400 <350 <350 <400

O2 <400 NA <500 <400

ACCURACY

Agent, volume % ±(0.15 vol% + 5% of reading) ±0.2 + 15% relative 0.15 ± 15% relative ± (0-15 vol% + 5% of reading)

N2O, volume % ±(2 vol% + 2% of reading) ±2 + 8% relative 2% + 8% relative ± (2 vol% + 2% of reading)

CO2, mm Hg ≤(0.2 vol% + 2% of reading) ±3.3 or 8% relative 0.5% + 12% relative (whichever is greater)

± (0.2 vol% + 2% of reading)

O2, volume % ±(1 vol% + 2% of reading) NA ±3 ± (1 vol% + 2% of reading)

CALIBRATION Biannual Automatic Not required; annual inspectionrecommended

External gas mixture

WATER TRAP VOL, mL Not specified 13 (reusable) >20 Not specified

OPERATING TEMPERATURE

°C (°F) 10-40 (50-104) 10-40 (50-104) 10-40 (50-104) 10-40 (50-104)

DISPLAY TYPE Color LCD Electroluminescent Color CRT or TFT color LCD(various sizes)

CRT, LCD, or electroluminescentwith touchscreen

ALARM LIMITS HIGH/LOW, %

Agent Off-6, off-8 sevoflurane, off-20desflurane

0.1-7; 0.1-9.8 (sevoflurane),0.1-21.9 (desflurane)

Halothane, isoflurane, enflurane,0.1-7.5 vol%/0-7.4 vol%;sevoflurane, 0.1-9 vol%/0-8.9vol%; desflurane, 0.2-20vol%/0-19.8 vol%

User selectable

N2O High fixed at 82 82 vol% (fix high limit) 0-82 (high) User selectable

ETCO2 Off-100 1-75 mm Hg 20-76 mm Hg/10-75 mm Hg User selectable

Inspired CO2 Off-100 1-20 mm Hg 0-20 mm Hg (high) User selectable

O2 18-100 NA 19-100 vol%/18-99 vol% (low,optional)

User selectable

ADDITIONAL ALARMS Apnea, occlusion, respiratory rate Apnea, SpO2, pulse Apnea, AWRR, various technicalalerts

Respiration rate (high/low),apnea, water trap full/missing,filter door open, occlusion, MAC, AGEMAC

ALARM SILENCE Yes Yes Yes Yes

Temporary/permanent 120 sec/300 sec Yes/no Configurable: temporary 1, 2, or 3min, or infinite

User selectable

AUXILIARY OUTPUTS Analog, serial RS232 RS232 (RJ-45 connector) NoneLINE POWER, VAC 100-240 100-240 100-240 ±10% 100-240

Watts 80 <55 during warm-up; <45 duringoperation

45 External power supply

BATTERY Not specified Optional None Not specified

Type (number) Not specified Lithium-ion (not specified) NA NA

Operating time, hr Not specified >1 NA NA

Displaying page 1 of 2 for current modules (#1-4) above.





Manufacturer GE Healthcare USACardiocap 5<1>

Draeger Medical IncVamos Plus

Philips (Deutschland) GmbHIntelliVue G1 Anesthesia GasMonitoring

Spacelabs Healthcare IncUltraview SL 91518 Multigas Analyzer

Rechargeable Not specified Yes NA NA

Recharging time, hr Not specified 10 NA NA

Low-battery notice Not specified Yes NA NA

H x W x D, cm (in) 30.1 x 33.2 x 22.2 (11.8 x 13 x 8.7) 16.6 x 24 x 16.6 (6.5 x 9.5 x 6.5) 8.5 x 30 x 23.2 (3.35 x 11.81 x9.13)

17.2 x 15.2 x 28.5 (6.8 x 6 x 11.2)

WEIGHT, kg (lb) 11.2 (24.8) 1.9 (4.2) <4 (8.8) 3.7 (8.2)

PURCHASE INFORMATION

List price $14,200<2> Not specified Not specified $12,700

Warranty 1 year 1 year 1 year 1 year

GREEN FEATURES None specified None specified None specified None specified

OTHER SPECIFICATIONS Fully integrated modular monitoring system; automaticidentification for 5 agents; 6waveforms; color, configuredmonitor; optional sidestreamspirometry and neuromuscular transmission monitoring.

Optional pulse oximetry, batterybackup.

Modular component of aphysiologic monitoring system(IntelliVue family). Meetsrequirements of with CSA, IEC,and UL.

Automatic pressure andtemperature compensation;menu-driven touchscreenoperation (via monitor) for easeof use; easy-access filter system;standby mode allows analyzer toremain warm between cases;short-term battery operation for main power failure. Meetsrequirements of CSA and ETL.

UMDNS CODE(S) 17445 17445 17445 17445

LAST UPDATED February 2011 August 2013 August 2013 February 2011

Supplier Footnotes

Model Footnotes <1>Formerly sold under Datex-Ohmeda.

Data Footnotes <2>Includes hemodynamics.



Multiple Medical Gas Monitors, Respired_Anesthetic_090313084140

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