徕卡与蔡司参数对比

显微镜参数对比
注：
经实际测量，立柱式方案中，由四张桌子的中心点到医生的操作距离（包括整
个头模拉出，医生坐在操作椅上操作），应该不小于1500mm,徕卡显微镜无论
是M300或是M320的工作距离，足够完成医生的需求，并且可以做到最舒适！
LEICA M525 DENT vs ZEISS PROergo
牙科手术显微镜技术对比
高端品牌，有徕卡皇族、蔡司贵族
注：
国际某知名品牌的40例灼伤报告：
http：///scripts/cdrh/cfdocs/cfMAUDE/textsearch.cfm
以上是FDA的网站，请写入pentero，按下search键
（pentero是蔡司价值最高端显微镜）
Company Model Type rep.Date MDR Key ev.type notes
CARL ZEISS SURGICAL OPMI PENTERO 07.10.09 1552721 Injury patient burn
CARL ZEISS SURGICAL OPMI PENTERO 22.09.09 1487302 Injury 2nd degree patient burn
CARL ZEISS SURGICAL OPMI PENTERO 28.08.09 1463653 Injury 3rd degree patient burn
CARL ZEISS SURGICAL OPMI PENTERO 21.05.09 1417983 Injury patient burn
CARL ZEISS SURGICAL OPMI PENTERO 02.03.09 1341655 Injury patient burn
CARL ZEISS SURGICAL OPMI PENTERO 19.12.08 1272491 Injury material
CARL ZEISS SURGICAL OPMI PENTERO 06.10.08 1190047 Injury burn
CARL ZEISS SURGICAL OPMI PENTERO 05.09.08 1149604 Injury light caused 3rd degree burns
CARL ZEISS SURGICAL OPMI PENTERO 05.09.08 1149683 Injury Patient Outcome Disability
CARL ZEISS SURGICAL OPMI PENTERO 02.06.08 1054098 Injury burn "level 2"
CARL ZEISS SURGICAL OPMI PENTERO 24.04.08 1034581 Injury patient burn on the right ear
CARL ZEISS SURGICAL OPMI PENTERO 26.03.08 1019975 Injury Required Intervention
CARL ZEISS SURGICAL OPMI PENTERO 28.09.07 920473 Injury 2nd degree burn during nerve repair
CARL ZEISS SURGICAL OPMI PENTERO 27.09.07 920471 Injury chemical burn
CARL ZEISS SURGICAL OPMI PENTERO 09.08.07 891533 Injury 3rd degree
CARL ZEISS SURGICAL OPMI PENTERO 22.06.07 869876 Injury 3rd degree burn
CARL ZEISS SURGICAL OPMI PENTERO 04.06.07 859125 Injury burn
灼伤案例：
/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1149604
MAUDE Adverse Event Report: CARL ZEISS MEDITEC,
INC.OPMI PENTERO OPERATING
MICROSCOPENONE
CARL ZEISS MEDITEC, INC. OPMI PENTERO
Back to Search Results OPERATING MICROSCOPE NONE
Event Date 03/02/2007
Event Type Injury Patient Outcome Disability
Event Description
The microscope light caused 3rd degree burns and
permanent nerve damage to the interior and exterior of
the ear. Thirty percent of right ear tissue is gone and pt
has no feeling in the interior or exterior of the right ear.
The intensity of the light was set at 30%. However, it was
noted by the attending md that it increased to near 100%
as the surgery progressed.
Search Alerts/Recalls20
New Search | Submit an Adverse Event Report21
Brand Name OPMI PENTERO OPERATING MICROSCOPE
Type of Device NONE
CARL ZEISS MEDITEC, INC.
Manufacturer (Section F)
dublin CA
CARL ZEISS MEDITEC, INC.
Manufacturer (Section D)
dublin CA
Device Event Key 1167524
MDR Report Key 1149604
Event Key 1102095
Report Number MW5008195
Device Sequence Number 1
Product Code HRM22
Report Source Voluntary
Reporter Occupation RISK MANAGER
Type of Report Initial
Report Date 09/05/2008
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received 09/05/2008
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator Health Professional
Is The Reporter A Health Professional? Yes
Was The Report Sent To Manufacturer? No
Is this a Reprocessed and Reused Single-Use Device? No
Is the Device an Implant? No
Is this an Explanted Device?。