ASTM_F_1463_-_93_1999.pdf

Designation:F 1463 93(Reapproved 1999)Standard Specification forAlarm Signals in Medical Equipment Used in Anesthesiaand Respiratory Care1This standard is issued under the fixed designation F 1463;the number immediately following the designation indicates the year oforiginal adoption or,in the case of revision,the year of last revision.A number in parentheses indicates the year of last reapproval.Asuperscript epsilon(e)indicates an editorial change since the last revision or reapproval.INTRODUCTIONMedical practice in hospitals is increasingly dependent on equipment for observation and treatmentof patients.Sounds and lights are frequently used to indicate the patients physiological status and thefunctional state of the equipment.The sounds used are frequently too loud and not sufficientlydistinctive,and it is often difficult to identify which item of equipment is signalling.The purpose ofthis specification is to specify signals,both audible and visual,to be used to draw attention to the factthat equipment has detected a disturbance and to indicate the degree of urgency.The content of this specification was developed with contributions from clinicians,engineers,applied psychologists,and musicians.Some of the criteria considered during development of thesounds included optimal signal recognition in a relatively noise-filled environment,maximumtransmission of information at the lowest practical sound pressure level,ease of learning and retentionby operators who have to respond to the various signals,and perceived urgency of the sounds.1.Scope1.1 This specification covers defining the characteristics andrequirements of electrically generated alarm signals for usewith medical equipment intended for use in anesthesia andrespiratory care.It does not specify the condition that activatesthe alarms,nor does it specify the devices used for theproduction of audible and visual signals.This specificationdoes not address informational sounds produced by devicessuch as ECG monitors,surgical lasers,and electrocauteryunits.1.2 The values stated in SI units are to be regarded as thestandard.2.Referenced Documents2.1ISO Standard:ISO 3744:AcousticsDetermination of Sound Power Lev-els of Noise SourcesEngineering Methods for Free-Field Conditions Over a Reflecting Plane22.2 IEC Standards:2IEC 651Sound Level MetersIEC 73 Colors of Indicator Lights and Push-Buttons3IEC 601-1Medical Electrical EquipmentPart 1:GeneralRequirements for Safety33.Terminology3.1 Definitions:3.1.1 bursta group of pulses with a distinctive rhythm.3.1.2 burst amplitudetheA-weighted sound pressure levelof the maximum pulse in the burst measured in decibels.3.1.3 burst spacingthe period of time between the start ofthe first pulse in one burst and the start of the first pulse in thenext burst.3.1.4 clearly legiblethe visual attribute of informationdisplayed by the equipment that allows the operator to discern(or identify)quantitative values or functions under a specificset of environmental conditions.3.1.5 discriminatethe ability of an operator to perceive aqualitative difference among visual signals under a specific setof environmental conditions.3.1.6 flashing frequencythe number of light flashes perunit of time.3.1.7 high priority alarma combination of audible andvisual signals indicating that immediate operator response isrequired.1This specification is under the jurisdiction of ASTM Committee F29 onAnesthetic and Respiratory Equipment and is the direct responsibility of Subcom-mittee F29.15 on Harmonization of Alarms.Current edition approved Feb.15,1993.Published June 1993.2Available from American National Standards Institute(ANSI),25 W.43rd St.,4th Floor,New York,NY 10036.3Patterson,R.D.,Guidelines for Auditory Warning Systems on Civil Aircraft,Civil Aviation Authority(UK)Paper 82017,1982.1Copyright ASTM International,100 Barr Harbor Drive,PO Box C700,West Conshohocken,PA 19428-2959,United States.3.1.8 low priority alarma visual signal,or a combinationof audible and visual signals indicating that operator awarenessis required.3.1.9 medium priority alarma combination of audible andvisual signals indicating that prompt operator response isrequired.3.1.10 overall pulse durationthe time over which thepulse amplitude exceeds 10%of the maximum amplitude.3.1.11 pulsea sound having a specific frequency spectrumand specific duration.3.1.12 pulse frequencythe fundamental frequency of thepulse.3.1.13 pulse spacing(within a burst)the period of timebetween the start of one pulse and the start of the next pulse.4.General Requirements4.1 High Priority Alarm SignalAhigh priority signal shallhave the characteristics given in Table 1.4.2 Medium Priority Alarm SignalA medium prioritysignal shall have the characteristics given in Table 1.4.3 Low Priority Alarm SignalAlow priority alarm signalshall have the characteristics given in Table 1.4.4 When an alarm signal is generated,the cause of thealarm shall be indicated.NOTE1This requirement is satisfied if the monitored variable