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ウクライナ認証機器について
ウクライナ認証済医療機器のウクライナ国立癌研究センター作成プロットコル概要の紹介(英文)と実施機関(ウクライナの病院・クリニック)の症例報告をご紹介します。(注:日本未承認機器)
ここでは、症例事例の共有を目的としているため、実施機関名等の情報は一部割愛します。
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1.Intended use
〇〇〇〇〇 is an apparatus for
cauterizing and solidifying a living body tissue (affected part) of a human
being by utilizing a cylindrical micro microheater (hereinafter simply
referred to as "micro heater") which is electrically heated and
has a minute diameter and a tip sealed . A he ater wire (hereinafter referred
to as "heater") which is insulated from the living body in the
vicinity of the tip of the microheater and a thermocouple for incorporating
a thermocouple for temperature measurement and temperature control of the
heater. The heater is heated by passing a current through a heater, the
temperature is measured with a thermocouple, and the temperature is controlled
by controlling the current flowing through the heater.
2.specification
2-1. Electrical specifications
Power-supply voltage AC100V 10% 240V 10%
Power frequency 50/60Hz
Input Power 100VA
Standard compliance
Medical field technical standard
(October 2, 2013 Ukraine Cabinet Office enacted NC lass: Class2A
2-2 Machine specification Size
Width 290 mm × height 185 mm × depth 292 mm
weight 5.8kg
2-3 Operating environment condition
temperature10 40
Humidity 30 75%RH
Atmospheric pressur 700 1060hPa
3.Appearance · Function explanation
Explanation of the name of each part of the device
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ウクライナ民間クリニックによる良性腫瘍(乳腺嚢胞)治療20症例報告
18症例CR・2症例PR |
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ウクライナ国立がんセンター病院での切除不能膵臓癌治療60症例報告
57症例PR・3症例SD(全症例共、再発膵臓癌) |
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○ |
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ウクライナ国立がんセンター病院での類骨骨腫3症例報告
3症例CR (1年後再発無) |
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ウクライナ国立がんセンター病院での前立腺癌・肺癌・乳癌等の骨転移治療10症例報告
9症例PR・1症例SD |
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