医疗器械可用性报告模板中英文版(用于MDR)Word下载.docx
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医疗器械可用性报告模板中英文版(用于MDR)Word下载.docx
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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
操作
Operate
测量结果获取
Checkthe
Comfort测量准备时长
Measure
备注
Remark
附件名称
Annexname
Theteststatisticsarecollectedinthefollowingtables.Forspecifictestrecords,pleaserefertoannex1~annex15.
information
preparationtime
Annex1
Annex2
Annex3
Annex4
Annex5
Annex6
Annex7
Annex8
Annex9
Averagescore
3.7
3.6
3.9
3.4
/
易
Us
Annex10
Annex11
Annex12
Annex13
Annex14
Annex15
整体感
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
3.8
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
supplyisswitched
on,thepoweronselftest.
开机后有自检提示?
2.
Afterthepoweronhasself-testtips?
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
COAG"
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
≥90%
95%theminimumtrainingamateuruser/professionaluserstosetthesystem,for2minutesorshorterperiodoftimeincluding:
time/date,language,voice,restorethedefaultsettings
plateline,thenegative90%theminimumtrainingamateurusersor
plateispastedontheskeletalmuscleofpatientswithpartoftherich
Takingmeasurements
buttonfortissuecutting
keytocoagulation
Duringoperationaccordingtotheoperationmodeandtheneedfortimelyadjustmentofoutputpower,andurgeall
95%professionaluserscanin1minutesorlesstopastethenegativeplate.
90%theminimumtrainingamateurusersor95%professionaluserscanconnecttheelectricconnectorlinein1minutesorless
95%theminimumtrainingamateuruser/professionaluserscanstartdevicein30secondsorless.
95%theminimumtrainingamateuruser/professionaluserstostartmeasuringbuttonin30secondsorless.
90%theminimumtrainingamateurusersor95%professionaluserscanstartin30secondsorless.
90%theminimumtrainingamateurusersor95%professionaluserscanin1minutesorshortertimeadjustmentmodeandoutputpower
levelsofpersonnelsafetyuseofelectricknife
Turndowndevice
cleaningdevice
95%theminimumtrainingamateur/professionaluserstoclosetheuserequipmentin30secondsorless.
90%theminimumtrainingamateur/professionaluserscandeterminetheuserequipmentfaulthasoccurredcorrectlyin5minutesorless,andtakeappropriatecorr
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