ASTM_F_1195_-_99.pdf

Designation:F 1195 99Standard Specification forRigid Laryngoscopes for Tracheal IntubationHook onFittings for Fiberilluminated Blades and Handles1This standard is issued under the fixed designation F 1195;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.INTRODUCTIONIn clinical anesthesia and resuscitation a variety of laryngoscopes are used.Because there is aclinical need for a variety of blade forms,they are manufactured as detachable blade and handle units.In the interest of patient safety,defined dimensions and performance standards are necessary.The aimof this specification is to ensure compatibility of rigid,folding,fiber-illuminated blades and handleswithin a given system without restricting innovation or design.1.Scope1.1 The purpose of this specification is to ensure thatreusable,detachable fiber-illuminated hook-on blade andhandle combinations that engage shall lock and illuminatewhen in the operating position.1.2 Dimensions and tolerances of fiber-illuminated systemsshall be provided.1.3 This specification provides methods of identifying bycolor the various fiber-illuminated systems and compatibleblades and handles within the system.1.4 This specification covers reusable handles and blades.Itdoes not cover disposable components or systems.1.5 Nonfiber-illuminated blades and handles with the lampin the blade shall conform to Specification F 965.2.Referenced Documents2.1 ASTM Standards:F 965 Specification for Rigid Laryngoscopes for TrachealIntubationHook-On Fittings for Laryngoscope Handlesand Blades with Lamps22.2Federal Standard:FED-STD-595A Colors33.Terminology3.1 Descriptions of TermsIn addition to the terms definedin Specification F 965,the following terms are defined:3.1.1 fiber-illuminated laryngoscope blade,na bladewhich utilizes optical fibers to transmit light from a source inthe handle.3.1.2 fiber-illumination handle,na hand-held rigid devicewhich provides a power source for illumination of a fiber-illuminated blade.It shall include the light source.3.1.3 contact/switch,ncomponents of the hook-on fit-tings,both handle and blade,which come in contact to energizethe light source when the blade and handle are in the locked,operating position.3.1.4 engagement,nthe blade and handle are engagedwhen mechanically attached and the blade remains coupled tothe handle in all positions.3.1.5 operating position,nthe position of the engagedblade and handle when illumination is produced and theinstrument is ready for use.4.Performance Requirements4.1 BladeandHandleFittingsDetachablefiber-illuminated blade and handle combinations that engage shalllock and illuminate when in the operating position,and shallhave the same color identification(see Section 7).4.2 Mechanical RestrictionsFiber-illuminated bladesshall be mechanically incompatible with nonfiber-illuminatedhandles to prevent engagement(see Specification F 965).4.3 Blade RetentionThe blade shall be retained on thehandle in all attitudes when engaged.1This specification is under the jurisdiction of ASTM Committee F-29 onAnesthetic and Respiratory Equipment and is the direct responsibility of Subcom-mittee F29.13 on Laryngoscopes and Bronchoscopes.Current edition approved July 10,1999.Published October 1999.Originallypublished as F 1195-88(1993)e1.Last previous edition F 1195-88(1993)e1.2Annual Book of ASTM Standards,Vol 13.01.3Available from the Naval Publications and Forms Center,5801 Tabor Ave.,Philadelphia,PA 19120.1Copyright ASTM International,100 Barr Harbor Drive,PO Box C700,West Conshohocken,PA 19428-2959,United States.4.4 Corrosion ResistanceComponents should resist cor-rosion under conditions of normal use,including cleaning anddisinfecting procedures as specified by the manufacturer.4.5 Critical DimensionsAll handle hook-on fittings shallconform to the dimensions of one of the systems described byFig.1 and Fig.2.The hook-on blade fitting must engage,lock,and operate at any tolerance specified within any one of theFig.1 and Fig.2.The total clearance between the width of thehandle slot and the blade hook-on fitting shall not exceed 0.011in.(0.28 mm).4.6 Component CompatibilityAhandle and blade hook-onfitting which engage shall lock and illuminate.This featureshall also apply to handles which engage either nonfiber-illuminated or fiber-illuminated blades.5.Marking and Labeling5.1 All markings shall be legible and durable.5.2 The name or trademark of the manufacturer shall bemarked on the blade fitting and on the handle in an area not lessthan 10 mm2.In addition,the blade shall be marked with itssize,type,country of origin,and either s/s,or stainless,if madeof stainless steel.5.3 Manufacturers shall provide information concerningcleaning and disinfecting procedures in the package.5.4 Any removable fiber