靜脈定位儀技術參數
注冊證號:食藥監械(進)字2011第2312195號
1、 防電擊類型:B型
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(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次
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
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13、 正常工作條件：a)溫度:4℃ ~33℃。 b)相對濕度:5%~85%;
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14、 正常運輸條件：a)溫度:-20℃~50℃。b)相對濕度:5%~85%;
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15、 正常存放條件：a)溫度:-20℃~50℃。b)相對濕度:5%~85%
16、 探頭發出兩束激光: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%
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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：滬寶食藥監械經營許20220040號
標簽：靜脈定位儀 血管成像儀 靜脈照射儀
技術支持：阿儀網， (滬)-非經營性-2022-0060總訪問量：4528659
