医疗器械可用性报告模板中英文版(用于MDR).docx
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XX医疗器械有限公司CE技术文件
可用性验证报告
日期:
2021.04.15
NO.:
发布部门:
技术部
第1次修改
修订日期:
2021.04.15
版本:
A/1
Usabilityvalidationreport
可用性验证报告
ProductName(产品名称):
Models(型号):
Manufacturer(制造商):
Address(地址):
Compiledby:
Date:
comment:
Reviewed by:
Date:
Approvedby:
Date
RevisionHistory
Version RevisedContent
CompiledbyDate
ApprovedbyDate
A/0 First 2021.04.15 2021.04.18
一、评分Scoring
Data
日期
Place
地点
Auditor
观察员
1、用户背景记录表Sheetofbackgroundrecordofpersontested
SQ
Name
Gender
Age
Education
Height(cm)
Weight
Experienceof
编号
姓名
性别
年龄
background
教育背景
身高
(Kg)
体重
use
使用经验
2、用户评分数据分析Criteriaofusabilityscore
有关于机器合适性评估分数由1-5分来做评分,其中,分数达到3或者3以上表示合格。
(1-很糟糕,3-好,5-非 常好)
Accordingtousabilityevaluationevaluationscore,1-5gradesisrequesttoscorewithusabilitysurvey,withinwhich,
scorewith3oraboveisdeemedasqualified.
分值Scorevalue
使用者评分
Userscore1
2
3
4
5
评分说明
Descriptionofscore
很糟糕,器械需要改善全部通用性。
Awful,needcompletedtoimproveallfunctionofusability.
差,需要部分改善。
Bad,needtoimprove.
好,可以具体分析可能改善部分。
Good,possibletoanalyzeandverifysomeimprovement.
非常好,保持现有优良要素并可能性调整改善。
Grate,keeptheperformanceandverifysomeimprovement.
极好。
Excellent.
3、测试任务评分Scoringoftesttasks
测量前准备
Preparetouse
测试任务用户评分(1-5)
TestingUserRating(scorevalue1-5)
操作 测量结果获取
Operate Measurement
核对信息
Checktheinformation
准备
连接仪器
Preparation Instrumentation
测量
Measurement
结果
Result
舒适度
Comfort测量准备时长Measure
preparation
time
体验打分(1-5)
Usingexperience(scorevalue1-5)
易用性
Usability
外观
Appearance
操作性
Operability
稳定性
Stability
整体感觉
Overallfeeling
整体评分
Entiretyevaluation
4、评分统计ScoringStatistics
测试任务用户评分(1-5)
TestingUserRating(scorevalue1-5)
测量前准备
Preparetouse
操作
Operate
测量结果获取
Measurement
核对信息
Checkthe
准备
连接仪器
Preparation Instrumentation
测量
Measurement
结果
Result
舒适度
Comfort测量准备时长
Measure
备注
Remark
附件名称
Annexname
Theteststatisticsarecollectedinthefollowingtables.Forspecifictestrecords,pleaserefertoannex1~annex15.
information
preparationtime
3
4
3
3
4
3
Annex1
4
3
3
4
4
3
Annex2
5
4
4
4
5
4
Annex3
5
4
4
5
5
4
Annex4
3
4
3
3
4
3
Annex5
3
3
3
4
3
4
Annex6
3
4
4
4
4
3
Annex7
4
3
4
4
4
3
Annex8
4
3
4
4
3
3
Annex9
Averagescore
3.7
3.6
3.7
3.7
3.9
3.4
/
体验打分(1-5)
Usingexperience(scorevalue1-5)
易
Us
3
3
4
3
3
3
Annex10
3
3
3
3
3
3
Annex11
4
4
4
3
4
4
Annex12
4
5
4
5
5
4
Annex13
4
4
4
3
4
4
Annex14
4
3
4
3
3
3
Annex15
整体感
附件名称
整体评分
用性 外观 操作性 稳定性 觉 Annexnameability Appearance Operability Stability Overall Entirety
evaluation
feeling
4 3 4 4 4 4 Annex1
4
4
3
4
4
4
Annex2
5
5
5
4
4
5
Annex3
3
4
4
4
5
4
Annex4
3
4
3
3
4
3
Annex5
4
3
3
3
3
4
Annex6
4
4
4
4
3
4
Annex7
3
4
4
4
3
4
Annex8
4
4
4
4
4
4
Annex9
发布部门:
技术部
第1次修改
修订日期:
2021.04.15
XX医疗器械有限公司CE技术文件
可用性验证报告
日期:
2021.04.15
NO.:
版本:
A/1
4
4
3
4
3
4
Annex10
3
3
4
4
3
3
Annex11
4
5
4
3
4
4
Annex12
4
5
4
4
4
4
Annex13
4
3
4
4
4
4
Annex14
4
4
3
3
3
3
Annex15
Averagescore
3.8
3.9
3.7
3.7
3.7
3.9
/
5、结论Conclusion
Fromthestatisticabove,theaveragescoreofeverytestitemandthatofeverykindofexperiencearebothmorethan3.4,whichmeansgood.Andinmanysingletests,thetestingscoreisupto4,even5,withtheexperiencealsois4,whichmeansthepeopletestedhavegreatexperienceinthetests.
二、总体使用体验分析Analysisofoverallexperienceofthetestedpeople
1、使用调查表UsabilityEvaluationSheet
描述:
请勾选“是”或“否”于下列19个问题
Description:
Pleaseticktheresultforyesornoforallquestions.(Total19questions)
任务
连接电源线,接通电源,开机自检
Connectthepower
line,thepower
编号
No.
1.
使用过程考虑点的描述
Useconsiderationsdescription
应有对应评估项目列表?
Shouldhaveassessmentitemtab?
le
是 否
Yes No
备注
Remark
supplyisswitched
on,thepoweronselftest.
开机后有自检提示?
2.
Afterthepoweronhasself-testtips?
XX医疗器械有限公司CE技术文件
可用性验证报告
日期:
2021.04.15
NO.:
发布部门:
技术部
第1次修改
修订日期:
2021.04.15
版本:
A/1
系统设置
systemsettings
系统设置按钮/图标应清楚的标识,易于找到和触发?
3.
Systemsettingsbutton/iconclearlyidentified,easy
tofindandtrigger?
连接负极板线路Connectthenegative4.plateline
在说明书中详细说明负极板的粘贴位置?
Thepositionofthenegativeplateisdescribedindetailintheinstructions?
连接一次性高频电刀笔连接线
Highfrequencyelectrosurgicalpencilconnectinglineconnected
启动器械
Bootdevice
说明书中有详细说明一次性高频电刀笔连接线的连接方法?
5. Inthespecificationdetaileddescriptionofdisposablehigh-frequencyelectrosurgicalpencilconnectingwireconnectionmethod?
启动按钮设计在器械顶部右手食指方便触发处,易于触发?
6.
Thestartbuttoninthetoprightindexfingerdevice
designeasytrigger,easytotrigger?
按下开关按键三秒以上,才能打开主机电源?
7. Presstheswitchbuttontoopentheabovethreeseconds,thehostpowersupply?
开始测量Makingmeasurements
开始测量按钮应清楚的标识,易于找到和触发?
8.
Thestartbuttonclearlymarked?
按“CUT”键进行组 9.
织切割
按键设计应该清楚/明显?
Startbuttondesignclear/obvious?
Press"cut"button 在说明书中详细说明按键的位置及作用?
fortissuecutting 10. Thepositionandfunctionofthebuttonare
explainedindetailinthemanual?
按“COAG”键进行凝血
Press"COAG"
按键设计应该清楚/明显?
11.
‘COAG’buttondesignshouldbecleaorb/vious?
在说明书中详细说明按键的位置及作用?
buttontocoagulation
12.
Thepositionandfunctionofthebuttonareexplainedindetailinthemanual?
术中根据手术需要及时调整模式及输出功率,并督促各级人员安全使用电刀
Duringoperationaccordingtotheoperationmodeandtheneedfortimelyadjustmentofoutputpower,andurgealllevelsofpersonnelsafetyuseofelectrosurgical
pencil
关闭器械
Turnoffdevice
13.
14.
在说明书中详细说明各种模式及输入功率的设置方法?
Adetaileddescriptionofsettingmethodsofmodelandinputpowerandfunctioninthespecification?
关闭器械的按钮应清楚的标识,易于找到和触发?
Turnoffdevicebuttonisclearlymarked,easytofindandtrigger?
器械应具有一段时间不无操作自动关闭功能?
15. Foraperiodoftimewithoutequipmentshouldhavethefunctionofautomaticclosingoperation?
故障排除
Failureremove
16.
错误信息应给出清楚易理解的问题描述和对其如何处理的简单指令?
Errormessagesshouldgiveclear,easytounderstandproblemdescriptionsandsimpleinstructionsfor
howtohandlethem?
清洁器械
Devicecleaning
应说明何种清洁物质(如苯、汽油等)不能用于清洁器械?
17. Whatkindofcleaningmaterials(suchasbenzene,gasoline,etc.)shouldnotbeusedforcleaningexplainedininstruments?
所使用的清洁材料应为易于获得的普通清洁材料?
18.
Useofcleaningmaterialsiseasytoobtainthecleaningmaterials?
使用说明书
19.
Instructionforuse
使用说明书应清晰、完整、明确、易懂?
Theinstructionsisclear,complete,clear,easytounderstand?
2、统计与分析Statistics&Analysis
2.1Commonusagescenarios
Atotalof5peopleparticipatedinandcompletedthe,teasntdallofthemwerevolunteeredtoparticipate.ThecompletionresultsofeachtaskareshowninTable1:
Table1:
Teststatisticsofcommonusagescenarios
Number/percentageof
Task Usabilitygoals peoplewhohadachieved
thetarget
Acceptable
criterion
Verify
Connectthepowerline,thepowersupplyisswitchedon,thepoweronselftest
systemsettingsConnectthenegative
95%theminimumtrainingamateuruser/professionaluserstopowerandstartingin1minutesorshortertimeseries
5/100%
≥95%
Pass
5/100%
≥95%
Pass
5/100%
≥90%
Pass
5/100%
≥90%
Pass
5/100%
≥95%
Pass
5/100%
≥95%
Pass
5/100%
≥90%
Pass
5/100%
≥90%
Pass
5/100%
≥90%
Pass
95%theminimumtrainingamateuruser/professionaluserstosetthesystem,for2minutesorshorterperiodoftimeincluding:
time/date,language,voice,restorethedefaultsettings
plateline,thenegative90%theminimumtrainingamateurusersor
plateispastedontheskeletalmuscleofpatientswithpartoftherich
Highfrequencyelectrosurgicalpencilconnectinglineconnected
Bootdevice
Takingmeasurements
Press"cut"buttonfortissuecutting
Press"COAG"keytocoagulation
Duringoperationaccordingtotheoperationmodeandtheneedfortimelyadjustmentofoutputpower,andurgeall
95%professionaluserscanin1minutesorlesstopastethenegativeplate.
90%theminimumtrainingamateurusersor95%professionaluserscanconnecttheelectricconnectorlinein1minutesorless
95%theminimumtrainingamateuruser/professionaluserscanstartdevicein30secondsorless.
95%theminimumtrainingamateuruser/professionaluserstostartmeasuringbuttonin30secondsorless.
90%theminimumtrainingamateurusersor95%professionaluserscanstartin30secondsorless.
90%theminimumtrainingamateurusersor95%professionaluserscanstartin30secondsorless.
90%theminimumtrainingamateurusersor95%professionaluserscanin1minutesorshortertimeadjustmentmodeandoutputpower
levelsofpersonnelsafetyuseofelectricknife
Turndowndevice
Failureremove
cleaningdevice
Instructionforuse
95%theminimumtrainingamateur/professionaluserstoclosetheuserequipmentin30secondsorless.
90%theminimumtrainingamateur/professionaluserscandeterminetheuserequipmentfaulthasoccurredcorrectlyin5minutesorless,andtakeappropriatecorr