靜脈定位儀技術(shù)參數(shù)
注冊(cè)證號(hào):食藥監(jiān)械(進(jìn))字2011第2312195號(hào)
1、 防電擊類型:B型
2、 激光分類: Ⅱ類
3、 主機(jī)重量≤275g，主機(jī)尺寸≤5×6×20cm
4、 主機(jī):內(nèi)部電源設(shè)備;充電器和充電機(jī)座，內(nèi)置可換鋰離子電池
5、 醫(yī)用電氣設(shè)備安全通用要求:應(yīng)符合GB9706.1-2007的的耍求
6、 激光產(chǎn)的安全:設(shè)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(jī)連續(xù)(靜脈燈開啟)使用時(shí)間≥180min
9、 使用完全充電電池能夠完成的標(biāo)準(zhǔn)查看程序次數(shù)≥90次
10、 有效照射距離：10-45CM
11、 可顯示皮膚下0-10mm以內(nèi)靜脈血管
12、 充電時(shí)間(完全) ≤3h
;
13、 正常工作條件：a)溫度:4℃ ~33℃。 b)相對(duì)濕度:5%~85%;
;
14、 正常運(yùn)輸條件：a)溫度:-20℃~50℃。b)相對(duì)濕度:5%~85%;
:
15、 正常存放條件：a)溫度:-20℃~50℃。b)相對(duì)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(cè)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(cè)偏離誤差不超過0.05mm。
19、 超時(shí)沒置：該設(shè)置決定靜脈顯示燈關(guān)閉的時(shí)間長度。超時(shí)可設(shè)為0(無超時(shí)）、2min、5min或15min。
20、 反轉(zhuǎn)沒置：該設(shè)置將儀器投影區(qū)域的暗色(陰影)與亮色(紅色)反轉(zhuǎn),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(rèn)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(shí)間：2024/11/12 13:40:53
經(jīng)營許可證號(hào)：滬寶食藥監(jiān)械經(jīng)營許20220040號(hào)
標(biāo)簽：靜脈定位儀 血管成像儀 靜脈照射儀
技術(shù)支持：阿儀網(wǎng)， (滬)-非經(jīng)營性-2022-0060總訪問量：4529869
