静脉定位仪技术参数
注册证号:食药监械(进)字2011第2312195号
1、 防电击类型:B型
2、 激光分类: Ⅱ类
3、 主机重量≤275g，主机尺寸≤5×6×20cm
4、 主机:内部电源设备;充电器和充电机座，内置可换锂离子电池
5、 医用电气设备安全通用要求:应符合GB9706.1-2007的的耍求
6、 激光产的安全:设备分类符合GB7247.1-2001的要求
7、 电源200- 240V；AC：0-4A；频率50-60Hz
8、 完全充电后主机连续(静脉灯开启)使用时间≥180min
9、 使用完全充电电池能够完成的标准查看程序次数≥90次
10、 有效照射距离：10-45CM
11、 可显示皮肤下0-10mm以内静脉血管
12、 充电时间(完全) ≤3h
;
13、 正常工作条件：a)温度:4℃ ~33℃。 b)相对湿度:5%~85%;
;
14、 正常运输条件：a)温度:-20℃~50℃。b)相对湿度:5%~85%;
:
15、 正常存放条件：a)温度:-20℃~50℃。b)相对湿度:5%~85%
16、 探头发出两束激光:红色激光和红外激光
红色激光波长:642nm,±5%；红外激光波长:785nm,±5%
红色激光功率:20mw,±20%；红外激光功率:13mw,±20%
红色激光脉冲能量:5.14μJ,±2o%
红外激光脉冲能量:3.16μJ,±20%
:
17、 线扫描脉宽：9OOns,误差±20%
18、 血管探测精确度：在正确操作惜况下,没备放在静脉血管上方,所显示血管位置的两侧偏离误差不超过0.05mm。
19、 超时没置：该设置决定静脉显示灯关闭的时间长度。超时可设为0(无超时）、2min、5min或15min。
20、 反转没置：该设置将仪器投影区域的暗色(阴影)与亮色(红色)反转,以便用亮色或暗色显示静脉。
21、 符合中CFDA以及美FDA和欧洲CE认证
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
更新时间：2024/4/3 14:23:18
标签：
静脉定位仪 血管成像仪 静脉照射仪
技术支持：阿仪网， (沪)-非经营性-2022-0060总访问量：4329604
