1CE Technical File rollator.docx
- 文档编号:9834282
- 上传时间:2023-02-06
- 格式:DOCX
- 页数:11
- 大小:67.69KB
1CE Technical File rollator.docx
《1CE Technical File rollator.docx》由会员分享,可在线阅读,更多相关《1CE Technical File rollator.docx(11页珍藏版)》请在冰豆网上搜索。
1CETechnicalFilerollator
CETechnicalFileRollator
Compliancewith93/42/EECMedicalDeviceDirective
FileNumbering:
CM-CE-02
Version:
A/0
IssueDate:
2011-10-20
ReviseDate:
2011-10-20
DANYANGCOMEDHEALTHCARECO.,LTD.
Address:
No.3,BeiErHuanRoad,DanyangCity,
JiangsuProvince,China
ShanghaiInternationalHoldingCorp.GmbH(Europe)
Address:
Eiffestrasse80,20537Hamburg,Germany
RevisionHistorySheet
Date
DescriptionofChange
Originator
2011-10-20
IssuedthisTechnicalFile
Mrs.TianMingxia
TableofContent
1.CompanyInformation
1.1Companyprofile
DANYANGCOMEDHEALTHCARECO.,LTD.isaprofessionalManufacturer ofwheelchair,crutches,walkersandotherMedicaldevices.WearelocatedinDanyangCity,JiangsuProvince,China.
COMEDwouldliketosupply differentkindsofinnovativedesignandhighqualityMedicaldevicesonbothDomesticandGlobalMarket.Innovation,qualityandspeedareourdevelopingtheme. Fromthematerial totheproduction,inspection, wedoseriouslyineachstepinordertocontrolthequalitywell.
Goodfaith,Qualityfirst,BestserviceandAdvancedtechnologyareourbusinessprinciples.Wewillmeettoyourrequirementswithgoodqualityandservice.
COMEDwarmlywelcomefriendsallovertheworldtovisitandbuildcooperativelongtermrelationshipwithus!
1.2QualityManagementSystem
DANYANGCOMEDHEALTHCARECO.,LTDhasestablishedandismaintainingaqualitySystemwhichmeetsENISO13485:
2003/AC:
2009andMDDAnnexVII,andhasbeencertifiedbytheCertificationBodyofTÜVSÜDProductServiceGmbHin2011.ThecertificateNumberisQ1N110576766001.
1.3Manufacture
DANYANGCOMEDHEALTHCARECO.,LTD
ADD:
No.3,BeiErHuanRoad,DanyangCity,JiangsuProvince,China.
1.4ECRepresentative
ShanghaiInternationalHoldingCorp.GmbH(Europe)
ADD:
Eiffestrasse80,20537Hamburg,Germany
2.DeviceIntroduction
2.1GeneralInformation
2.1.1DeviceNameandType
DeviceName
Type
Rollators(wheeledwalkers)
CM401A,CM401B,
2.2.2IntendedUse
Rollators(alsocalledwheeledwalkers)helpssomeonewhocanusetheirlegsbutneedssupport.ItisaEuropeanstyle,withhand-brakesanda'shoppingcart',thelidofwhichcanbeusedasaseat.
2.2.3ClassificationandConformityRoute
RollatorsisoneoftheNon-invasivedevices.Accordingto93/42/EECAnnexIX,Rules1,itshouldbeinclassI.
TheConformityRouteisAnnexVII.
2.2.4ProductHistory
RollatorsinventedbytheSwedeAinaWifalkin1978.Itisaframewithwheels,andaseatplatterintheframetoallowtheusertostopandrestasneeded.Rollatorsaretypicallymoresophisticatedthanconventionalwalkerswithwheels.Theyareadjustableinheightandareequippedwithaseatandsometimeswithabasket;withtheuseofmodernmaterials,theyarelight-weightyetsturdier.Modernwheeledwalkersmayalsoprovideabackagainstwhichapersoncanlean.Aparticularlyimportantpartofarollatorishandbrakesmountedonthetopoftheframethatcanbeliftedorpusheddownwardtostopthewheeledwalkeratonce.Thebrakescanalsobeusedinmaneuveringtherollator;whenturning,theusercanbrakeonthesidebeingturnedtowardsinordertoachieveatighterturningradius.
2.2.5Appearanceofdevice
2.2LabelingandInstructionsofuse
2.2.1Labeling
AccordingtothestandardEN1040andEN980,thefollowingcontentsmustbecontainedinthelabel:
1.Symbolfor“MANUFACTURER”:
2.
Symbolfor“AUTHORISEDREPRESENTATIVEINTHEEUROPEANCOMMUNITY”:
3.ProductNameandModel;
4.WeightCapacity250lbs;
5.Symbolfor“SERIALNUMBER”:
6.Symbolfor“DATEOFMANUFATURE”:
7.Symbolfor“CAUTION”;
8.Symbolfor“KEEPDRY”:
9.Symbolfor“CE”:
2.2.2Labelsample
2.2.3Instructionsofuse
PleaserefertoAttachment1:
Owner'sOperatorandMaintenanceManual
2.3LanguageRequirement
Weherewithdeclarethatifapplicableinthememberstates,wewilltranslatetheusemanualintosuitablelanguagewhileputmarketonsuchEUmemberstates.
3.TechnicalInformation
3.1Maindocuments
PleaserefertoAttachment2:
Maindocumentsofdevice
3.2BOM
PleaserefertoAttachment3:
BOMofdevice
3.3Assemblydrawing
PleaserefertoAttachment4:
Assemblydrawingofdevice
3.4ModelandPerformance
TYPE
CM401A
CM401B
Overallwidth:
24"
24"
Widthbetweenhandles:
18.5"
18.5"
lengthadjust:
8"-22"
8"-22"
Handleheightadjust:
32"-38"
31"-36"
Seatwidth:
14"
14"
Seatdepth:
13"
13"
Seatheight
21"
20.5"
Basketforstorage
Big
Big
Wheels
8"
6"
Wheellocks:
Handbrake
Handbrake
Framefinish
ColorAvailable
ColorAvailable
WEIGHT**(APPROX.):
17pounds
14pounds
SHIPPINGWEIGHT**(APPROX.):
18pounds
15pounds
WEIGHTLIMITATION:
250lbs(110kg)
3.5TransportandStorage
ToensurethePackagecanpreventthedamageinsuchawaythatitscharacteristicsandperformancesduringitsintendedusewillnotbeadverselyaffectedduringtransportandstorage,thepackagemethodhasbeenverifiedwithacceptableresult.
PleaserefertotheAttachment5:
Thepackagemethods.
3.6Productionflowchat
PleaserefertoAttachment6:
Productionflowchatofdevice.
4.EssentialRequirementsConformity
PleaserefertoAttachment7:
EssentialRequirementsChecklist.
5.RiskManagementReport
PleaseseetheAttachment8:
RiskManagementReport.
6.ECHarmonizedStandardsApplicableinProduction
SN
DocumentNo.
EditionNo.
Title.
1
ISO13485:
2003
2003
Medicaldevices-Qualitymanagementsystems-Requirementsforregulatorypurposes
2
EN980
2008
Symbolsforuseinthelabellingofmedicaldevices
3
EN1041
2008
Informationsuppliedbythemanufacturerofmedicaldevices
4
BSEN1985
1999
BSEN1985-1999Walkingaids-Generalrequirementsandtestmethods
5
ISO11199-2
2005
Walkingaidsmanipulatedbybotharms-Requirementsandtestmethods-Part2:
Rollators
6
ENISO9999
2007
Assistiveproductsforpersonswithdisability-Classificationandterminology
7
ENISO14155-1
2009
Clinicalinvestigationofmedicaldevicesforhumansubjects-Part1:
Generalrequirements(ISO14155-1:
2003)
8
ENISO14155-2
2009
Clinicalinvestigationofmedicaldevicesforhumansubjects-Part2:
Clinicalinvestigationplans(ISO14155-2:
2003)
9
ENISO14971
2009
Medicaldevices-Applicationofriskmanagementtomedicaldevices(ISO14971:
2007)
7.TestingReports
PleaseseetheAttachment9:
ISO11199-2:
2005testingreport.
8.ClinicLiterature
8.1Historyintroductionofproduct
RollatorsinventedbytheSwedeAinaWifalkin1978.Itisaframewithwheels,andaseatplatterintheframetoallowtheusertostopandrestasneeded.Rollatorsaretypicallymoresophisticatedthanconventionalwalkerswithwheels.Theyareadjustableinheightandareequippedwithaseatandsometimeswithabasket;withtheuseofmodernmaterials,theyarelight-weightyetsturdier.Modernwheeledwalkersmayalsoprovideabackagainstwhichapersoncanlean.Aparticularlyimportantpartofarollatorishandbrakesmountedonthetopoftheframethatcanbeliftedorpusheddownwardtostopthewheeledwalkeratonce.Thebrakescanalsobeusedinmaneuveringtherollator;whenturning,theusercanbrakeonthesidebeingturnedtowardsinordertoachieveatighterturningradius.
Also,totheadvantageofsafety,convenience,anddurabilityofawheeledwalkingaidanditsparts,modernrollatorsusetubularseats,backseatsandbasketswithspacersandcushions,andratherthanusingsimplehooksasinearlymodels,areequippedwithlatchesandreleasebuttons.Althoughsomepeoplemaynotconsiderthemtobewalkers,rollatorsarebasicallyadjustablewalkerswithwheelsattachedtothebottomofthelegs.Theadvantageofthewheelsisthatyoudon'thavetoliftthewalkertogoforwardorbackward.YoujusthavetorollthewalkeralongthegroundtogetfrompointAtopointB.Thismakesitmucheasiertogetaroundasthewheelsaredesignedtoturn,pivotandmaneuverinawaythatwalkerscan't.
8.2ThemainstructureandfunctionofRollators
Rollatorscomeinvariousmaterials,sizes,shapes,designs,stylesandcolors.It'simportantthatyourrollatoristhepropersizeforyou.Youshouldn'thavetobendorreachtouseitandyourwristsshouldlineupwiththerollator'shandles.Makesurethattherollatoryoubuyisabletohandleyourbodyweight.Mostmodelswillhaveamaximumweightcapacity.Youcanalsogetaccessoriesforyourrollatorsuchasremovablestoragebaskets,traysanddrinkholders,however,somemodelsofrollatorswillcomewithabasketalreadyattachedtothem.
1)Frame
Therollatorframehelpstosupportyourbodyweight.Theyalsohelpyoutokeepyourbalanceandposture,andtheytakesomeofthepressureoffofyourlegs.Framesaregenerallymadeofsturdy,anti-rustaluminumandweighbetween10and30pounds.Somerollatorsarerigid,buttherearemanyfoldablemodelsavailable.Foldablerollatorsaregenerallylighter,makingthemeasytopack,storeandcarry.
2)Wheels
Rollatorswithsmallerwheelsareaimedatindooruse;whilerollatorswithbiggerwheelsareidealforoutdooruse.Modernrollatorsforoutdoorwithwheelsatleastseveninchesindiameterensurebetterreliability.
3)Handles
Adjustablehandleheightaccommodatesmostusers.
4)HandBrakes
Aparticularlyimportantpartofarollatorishandbrakesmountedonthetopoftheframethatcanbeliftedorpusheddownwardtostopthewheeledwalkeratonce.Thebrakescanalsobeusedinmaneuveringtherollator;whenturning,theusercanbrakeonthesidebeingturnedtowardsinordertoachieveatighterturningradius.
5)SeatplatterandBackrest
Mostrollatorsalsohave
- 配套讲稿:
如PPT文件的首页显示word图标,表示该PPT已包含配套word讲稿。双击word图标可打开word文档。
- 特殊限制:
部分文档作品中含有的国旗、国徽等图片,仅作为作品整体效果示例展示,禁止商用。设计者仅对作品中独创性部分享有著作权。
- 关 键 词:
- 1CE Technical File rollator CE