ASTM_F_1831_-_97_2014.pdf

Designation:F183197(Reapproved 2014)Standard Specification forCranial Traction Tongs and Halo External SpinalImmobilization Devices1This standard is issued under the fixed designation F1831;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()indicates an editorial change since the last revision or reapproval.1.Scope1.1 This specification covers standards a manufacturer shallmeet in the designing,manufacturing,testing,labeling,anddocumenting of halo and tong external spinal immobilizationdevices,but it is not to be construed as production methods,quality control techniques,manufacturers lot criteria,or clini-cal recommendations.1.2 This specification represents the best currently availabletest procedures at this time and is a minimum safety andperformance standard.1.3 This specification covers only those halo and tongdevices intended for use on humans for therapeutic purposes.This specification assumes the user is well-trained in theprocedures and maintenance of halo and tong application andhas the ability to determine if an abnormality is treatable bythese procedures.1.4 This specification describes those devices commonlyknown as halo external fixation devices and what is known ascranial traction tongs.1.5 Cranial traction tongs and halo devices are used toachieve and maintain optimal spinal alignment,in order toenhance fusion and decrease neurological deficit.1.6 Monitoring the progress of treatment after application ofthese devices is important,this should be done in accordancewith the manufacturers recommendation and guidelines per-taining to the specific device.1.7 The values stated in both inch-pound and SI units are tobe regarded separately as the standard.The values given inparentheses are for information only.1.8 The following precautionary statement pertains only tothe test method portions Sections 10 15 of this specification-:This standard does not purport to address all of the safetyconcerns,if any,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 IEC Standard:IEC 601-1 Medical Electrical Equipment23.Terminology3.1 Definitions of Terms Specific to This Standard:3.1.1 cranial traction tonga device providing weightedcervical traction to a patient through invasive attachment to theskull.This traction instrument is indicated for closed reductionof a cervical spine injury(that is,fracture or dislocation).3.1.1.1 adjustable tonga cranial traction tong that adjustsfor size,pin positioning,or pin pressure.3.1.1.2 one-piece tonga rigid,single-piece,semicircularcranial traction tong designed to accommodate a minimum oftwo skull pins for mounting the device to the patients headbelow the equator.3.1.2 halo devicean external fixator for cervical stabiliza-tion that fastens by invasive means to a patients skull,andmaintains the position of the skull in relation to the thoracicarea of the patient.3.1.3 halo ringthe portion of the halo device that fastensby invasive means to a patients skull below the head equator.3.1.3.1 closed loop halo ringa halo ring incorporating aclosed loop anywhere in the design for purposes of structuralintegrity when the ring is in use.This type of ring has multiplepositioning options for the selection of pin sites and is mountedto the head with multiple skull pins.3.1.3.2 head equatorthe greatest circumference of thehead in the coronal aspect.3.1.3.3 open loop halo ringa halo ring with a posterioropening,such that the part does not incorporate a closed loopanywhere in the design for structural integrity.This ring has1This specification is under the jurisdiction of ASTM Committee F04 onMedical and Surgical Materials and Devices and is the direct responsibility ofSubcommittee F04.31 on Neurosurgical Standards.Current edition approved Oct.1,2014.Published November 2014.Originallyapproved in 1997.Last previous edition approved in 2006 as F1831 97(2006).DOI:10.1520/F1831-97R14.2Available from American National Standards Institute(ANSI),25 W.43rd St.,4th Floor,New York,NY 10036,http:/www.ansi.org.Copyright ASTM International,100 Barr Harbor Drive,PO Box C700,West Conshohocken,PA 19428-2959.United States1 multiple position options for the selection of pin sites and ismounted to the head with multiple skull pins.3.1.4 halo superstructurea rigid external framework usedto maintain positioning of the skull and cervical spine inrelation to the thoracic and lumbar spine.Connects the haloring to halo vest.3.1.4.1 halo superstructure adjustment mechanismscomponents that allow adjustment of angles and distancesbetween ring and uprights or vest and uprights.3.1.4.2 transverse bara rigid horizontal component of thehalo superstructure.3.1.4.3 upright bara rigid