ASTM_F_1246_-_91_1999.pdf

Designation:F 1246 91(Reapproved 1999)Standard Specification forElectrically Powered Home Care Ventilators,Part1Positive-Pressure Ventilators and Ventilator Circuits1This standard is issued under the fixed designation F 1246;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.1.Scope1.1 This specification covers all electrically powered lungventilators and ventilator circuits specifically intended for usein the home environment,and marketed after the final date ofapproval for this specification.Breathing circuits intendedspecifically for use with home care ventilators are also includedwithin the scope of this specification.The application ofcritical care ventilators,anesthesia ventilators,emergency caretransport ventilators,and resuscitators in the home environ-ment is not covered by this specification.As well,thisspecification does not cover high frequency ventilators orexternal body ventilators.Part 1 of this specification addressespositive pressure ventilators,and Part 2 addresses negativepressure ventilators.(See also X1.1.1.)1.2 The values stated in SI units are to be regarded asstandard.1.3 The following precautionary caveat pertains to the testmethod portion only,Section 6,of this specification.Thisstandard may involve hazardous materials,operations,andequipment.This standard does not purport to address all of thesafety problems associated with its use.It is the responsibilityof the user of this standard to establish appropriate safety andhealth practices and determine the applicability of regulatorylimitations prior to use.2.Referenced Documents2.1 ASTM Standards:F 1054 Specification for Conical Fittings of 15 mm and 22mm Sizes23.Terminology3.1 Definitions of Terms Specific to This Standard:3.1.1 breathing systemgas pathways in direct connectionwith the patient through which intermittent or reciprocating gasflow occurs and into which a mixture of controlled compositionmay be dispensed.3.1.2 end-expiratory pressurepressure in the breathingsystem at the end of the expiratory phase time,prior to thebeginning of the inspiratory phase time.3.1.3 expiratory phase time,(TE)interval from the start ofexpiratory flow to the start of inspiratory flow.3.1.4 home care ventilatorventilator intended for use inthe home environment.3.1.5 home environmentthe patients place of residenceoutside the hospital.This usually refers to the patients home,but may include nursing homes,and personal or other means oftransportation.3.1.6 inspiratory phase time,(TI)interval from the startof inspiratory flow to the start of expiratory flow.3.1.7 maximum limited pressure,(PL max)highest gagepressure that can be attained in the patient system duringmalfunction of the ventilator,but with functioning safetymechanisms.3.1.7.1 DiscussionThis term has not been changed inaccordance with ISO 4135,however,the text is identical.TheISO term is“maximum safety pressure.”3.1.8 maximum working pressure,(Pw max)highest gagepressure that can be attained in the patient system during theinspiratory phase when the ventilator is functioning normally.3.1.8.1 DiscussionThis may be limited by a controllableventilator mechanism to less than PLmax.3.1.9 patient connection portthat opening at the patientend of an expiratory valve unit;a Y-piece fitting or a unidirec-tional valve to which may be connected either a tracheal tubeadaptor or a face mask angle piece.3.1.10 patient systemthat part of the gas system of aventilator through which respired gas travels at appropriaterespiratory pressures.3.1.11 peakpressurethemaximumgagepressureachieved during the inspiratory phase time,with all pressurelimiting mechanisms functioning.3.1.12 positive end-expiratory pressure(PEEP)pressure,patient system,(Pps)at the end of expiration,above ambient.3.1.13 pressure,patient system(Pps)pressure at a speci-fied point in the patient system.3.1.14 ventilatora device capable of automatically maintaining or replacing a patients entire pulmonary ventilation.1This specification is under the jurisdiction of ASTM Committee F29 onAnesthetic and Respiratory Equipment and is the direct responsibility of Subcom-mittee F29.14 on Ventilators.Current edition approved April 15,1991.Published June 1991.2Annual Book of ASTM Standards,Vol 13.01.1Copyright ASTM International,100 Barr Harbor Drive,PO Box C700,West Conshohocken,PA 19428-2959,United States.3.1.14.1 DiscussionConditions under which measure-ments are made shall be given.3.2 Descriptions of Abbreviations Specific to This Standard:3.2.1 Cindicates compliance in units of mL/kPa(ormL/cm H2O),for example,C 20=2.0 mL/kPa(20 mL/cmH2O).3.2.2 Rindicates resistance to flow in units of kPa/L/s(orcm H2O/L/s),for example,R5=0.5 kPa/L/s(5 cm H2O/L/s).NOTE1In the interest of brevity and clarity,all other abbrevia