麻醉机技术TF FINGS 2221临床与技术优化报告.pdfVIP

1)Intendedusedescriptionisnotidentical(for“newborns”):

User’smanual:DocumentNo.：NR-TP-2221-004Version：A1,chapter3.1

…suitableforadult、childrenandnewborns.

Clinicalevaluationreport:NR-TU-2221-019,VersionA1

1.2.2Descriptionofintendeduse

…suitableforadultandchildren.补充增加newborns

riskmanagementreport:NR-TU-2221-021,VersionA1,chapter11.2:1.1.2

...foradultandchildren补充增加newborns

2)ForISO80601-2-13:2011report(NR-TS-2221-014,date2014.10.10)Table

201.13.101,

Alarmcyevidenceisnotcomplete.

9)Theprotectiveboardpowersupplyaret:12VAforCPUaredirectly

fromVuse(ACboardouputorbattery)byoneLDO.12VDforbuzzerarefromVuse

byanotherLDO.

12)TheVusecomefromACboardouput(15V)orbattery(11.1v).IfACpowerfail,the

batterycanprovidethepower.WhenACpowerisactive,thebatterywillbecharged,

ifthebatteryvoltagelow,thebatterywillbecharged.Ifthebatteryvoltagelow,the

mainboardwilltriggerthelowbatteryvoltagealarm.

13)The7visalsoantpower,itisdirectlyfromVuse.The7visthepower

ofinspvalve,PEEPvalveandsafevalve.TheVCMandprotectiveboardcancontrol

PEEPvalveandsafevalveopenorclose.Ifthe7vfail,theVCMboardsoftcanwork

normally,sotheVCMboardcansendalarminfortomainboard,andclosetheallthe

valve.

14)Inspvalvefail:

➢Atstartuptest,theVCMsoftwillcomparetheDACvalueandinspvalvefeedback

voltagetotestthedrivecircuit

➢Atstartuptestandworkmode,theVCMwillmonitorthe7vpowersupplyofinsp

valve.

➢Ifthevalveitselffail,cannotopennormally,theVCMwilltrig