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    產品名稱:

    靜脈定位儀,液晶定位儀AccuVein AV400

    產品型號:
    產品產地: 中國大陸
    訪問次數: 2405
    發(fā)布時間: 2017/4/10 10:42:41
    靜脈定位儀,液晶定位儀AccuVein AV400靜脈定位儀產地美
    血管探測精確度:在正確操作惜況下,沒備放在靜脈血管上方,。

    超時沒置:該設置決定靜脈顯示燈關閉的時間長度。超時可設為0(無超時)、2min、5min或15min。

    反轉沒置:該設置將儀器投影區(qū)域的暗色(陰影)與亮色(紅色)反轉,以便用亮色或暗色顯示靜脈。

    符合中
靜脈定位儀技術參數
 注冊證號:食藥監(jiān)械(進)字2011第2312195號
 
1、 防電擊類型:B
 
2、 激光分類: Ⅱ類
 
3、 主機重量≤275g,主機尺寸≤5×6×20cm
 
4、 主機:內部電源設備;充電器和充電機座,內置可換鋰離子電池
 
5、 醫(yī)用電氣設備安全通用要求:應符合GB9706.1-2007的的耍求
 
6、 激光產的安全:設備分類符合GB7247.1-2001的要求
 
7、 電源200- 240V;AC:0-4A;頻率50-60Hz
 
8、 完全充電后主機連續(xù)(靜脈燈開啟)使用時間≥180min
 
9、 使用完全充電電池能夠完成的標準查看程序次數≥90
 
10、 有效照射距離:10-45CM
 
11、 可顯示皮膚下0-10mm以內靜脈血管
 
12、 充電時間(完全) 3h
;
13、 正常工作條件:a)溫度:4 ~33℃。 b)相對濕度:5%~85%;
;
14、 正常運輸條件:a)溫度:-20℃~50℃。b)相對濕度:5%~85%;
:
15、 正常存放條件:a)溫度:-20℃~50℃。b)相對濕度:5%~85%
 
16、 探頭發(fā)出兩束激光:紅色激光和紅外激光
  
紅色激光波長:642nm,±5%;紅外激光波長:785nm,±5%
紅色激光功率:20mw,±20%;紅外激光功率:13mw,±20%
紅色激光脈沖能量:5.14μJ,±2o%
紅外激光脈沖能量:3.16μJ,±20%
 
:
17、 線掃描脈寬:9OOns,誤差±20%
 
18、 血管探測精確度:在正確操作惜況下,沒備放在靜脈血管上方,所顯示血管位置的兩側偏離誤差不超過0.05mm
 
19、 超時沒置:該設置決定靜脈顯示燈關閉的時間長度。超時可設為0(無超時)、2min、5min或15min。
 
20、 反轉沒置:該設置將儀器投影區(qū)域的暗色(陰影)與亮色(紅色)反轉,以便用亮色或暗色顯示靜脈。
 
21、 符合中CFDA以及美FDA和歐洲CE認證
 
Protocol Name:  Utilization of AccuVein Vein Illumination Device (AV-400) To Enhance First Attempt Success Rate for IV Placement in Multiple Patient Populations
 
 
 
STUDY SPONSOR:AccuVein, Inc.
40 Goose Hill Road
Cold Spring Harbor, New York 11724
Date:August 16, 2013
 
 
 
Confidential and Proprietary
Nothing herein is to be disclosed without the expressed written Consent of AccuVein, Inc.

Protocol Signature Page
 
I have read the attached protocol and agree that it contains all necessary details for carrying out this study. I will conduct the study in accordance with the design and specific provisions outlined herein; deviations from the protocol are acceptable only with a mutually agreed upon protocol amendment.
 
I will provide copies of the protocol and all pertinent information to all individuals responsible to me who assist in the conduct of this study. I will discuss this material with them to ensure they are fully informed regarding the device and the conduct of the study.
 
I will use the informed consent form approved by AccuVein, Inc. and will fulfill all responsibilities for submitting pertinent information to the Ethics Committee or other regulatory body responsible for this study.
 
I also agree to report all information or data in accordance with the protocol and, in particular, I agree to report any serious adverse experiences as defined in Section 8 of this protocol.
 
I further agree that AccuVein, Inc. and their designee has access to any source documents from which case report form information may have been generated. I also agree to handle all clinical supplies provided by AccuVein, Inc. in accordance with the protocol and study plan.
 
The below signed confirm herewith to have read and understood this trial protocol and/or amendment and appendices; furthermore, to accomplish this study in accordance to the protocol and Good Clinical Practice guidelines, as well as local regulations; and to accept respective revisions conducted by authorized personnel of AccuVein, Inc. and by competent authorities.
 
 
NAMESIGNATUREDATE
 
Dr. John Kelly _____________________________________________
Dr. Jeremy Aidlen
 

更新時間:2024/11/12 13:40:53


經營許可證號:滬寶食藥監(jiān)械經營許20220040號


標簽:靜脈定位儀   血管成像儀   靜脈照射儀   

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