Mindray XP8-2TU - Bite-Hole Inspection Test

TransducerControlsandInspection
24 Operator's Manual
Checkingtheintegrityoftheinsulatingmaterialcannotalwaysbeaccomplishedbyvisual
inspections.Aprogramformeasuringtheelectricalleakagecurrentonaregularbasis
shouldbeestablished.Asaminimum,leakagetestsaccordingtoEN60601-1/IEC60601.1
§19mustbeperformedonceayear,orasrequiredbylocalregulation.Theleakage
limitsassociatedwithTypeBFAppliedPartmustbemet.Thetestrequiresaccesstothe
ultrasoundsystemandtostandardizedtestequipment.Thetransducerhastobeimmersed
inaNormalSalinesolution(50gNaClperliterwater)toabovethe40cmmark(butbelow
thehandle).
Mindrayrecommendskeepingawrittenlogoftheresults.
3.3.2 Bite-hole Inspection Test
Bite-holesorotherdamagesoftheendoscopesurfacecanalternativelybedetected
byasimplifiedtestwithouttheaccesstotheultrasoundsystem,byusingthefollowing
procedure.Theobjectiveofthistestistodetectbite-holes.Itissafeandeasytoperform,
butisnotanisolationorleakagecurrenttestasdescribedinEN60601-1.Thetest
equipmentisshowningurebelow.
Figure 3-4 Connection with test equipment (for reference only)
OK
1 Waterbath
2 Copperoraluminumsheet
3 Multimeter
4 TEEtransducer
5 Positivelead
6 Negativelead
Test Setup
Assemblethefollowingitemsforthetest.
•
Waterbathwitha1Normalsalinesolution(50gNaCl/1literwater).