厂家直供瑞思驰体外辅助生殖用显微操作仪Integra 3
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品牌名称：$brandModel.Title型号： 原产地：中国大陆 医疗器械注册号(批文)：国械注进20202180209更新时间：2026/10/16 11:11:02
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厂家直供瑞思驰体外辅助生殖用显微操作仪Integra 3
桂经理19117326863微xin同号
桂经理19117326863微xin同号
管理类别
第二类
型号规格
Integra 3
结构及组成/主要组成成分
操作台底盘、嵌入式热台、加热载物台、热风系统（选配）、两个机械式显微操作器、两个微吸管持针器、两个持针器调节支架、两个手托、气压注射器（SAS和SAS-SE）、注射器管路、电源适配器组成。
适用范围/预期用途
该产品用于体外辅助生殖中在显微镜下定位微型工具，同时可以维持样品温度。供临床机构使用。
1、工作原理 Working Principle
中文：设备依托高精度机械显微操作机构，通过操纵手柄驱动 X/Y/Z 三轴精密传动组件，实现显微持卵针、注射针等微工具在显微镜视野下微米级位移定位；配套 Thermosafe™热风恒温系统，以均匀热风对培养皿样本进行温控，维持生殖细胞体外操作所需温度；气压 / 油压注射器提供可控负压与注射压力，完成卵子固定、精子注射等显微操作，配合倒置显微镜完成体外辅助生殖显微操作流程CooperSurg...。English：The device adopts high‑precision mechanical micromanipulation mechanism. The joystick drives X/Y/Z three‑axis precision transmission components to realize micron‑level displacement positioning of micro‑tools such as holding pipettes and injection pipettes under the microscope. The supporting Thermosafe™ hot‑air constant‑temperature system provides uniｆorm hot‑air for petri dish samples to maintain required temperature for germ‑cell in‑vitro manipulation. Pneumatic/oil‑filled syringes deliver controllable negative pressure and injection pressure for oocyte holding and sperm injection, cooperating with inverted microscope for ART micromanipulation proceduresCooperSurg...。
2、功能 Function
中文：
在显微镜下对显微操作针进行三维精密定位，实现卵子固定、精子胞浆内注射（ICSI）等显微操作；
Thermosafe™恒温热台系统，维持培养样本操作温度，消除冷热斑；
支持气压 / 油压两种注射器，实现抽吸、平衡、注射压力调节；
触屏显示温度、计时、注射计数，电子高度标尺监控 Z 轴位移；
可外接电脑软件，完成图像采集、视频录制、数据存储输出。English：
3D precise positioning of micro‑pipettes under microscope for oocyte holding and ICSI (Intracytoplasmic Sperm Injection);
Thermosafe™ heated stage maintains sample temperature and eliminates hot/cold spots;
Support pneumatic and oil‑filled syringes for aspiration, equilibration and injection pressure adjustment;
Touch‑screen displays temperature, stopwatch, injection count; electronic height gauge monitors Z‑axis movement;
Connect to PC software for image capture, video recording and data export。
3、产品特点 Product Features
中文：
单手柄三轴联动控制，细调可达亚微米级分辨率，粗调快速位移；
持针器一键角度调节，角度 16‑40°，更换微吸管快速便捷；
Thermosafe™热风式恒温，温控精度优于 ±0.1℃，无局部冷热点；
集成 3.5 英寸彩色触控屏，运动感应 LED 补光；
兼容主流品牌倒置显微镜；整机占用空间小，热台面积增大 40%；
可选配 SAS 气压注射器、SOS 油压注射器两种压力控制单元。English：
Single‑joystick 3‑axis control, sub‑micron resolution for fine movement and fast coarse positioning;
One‑step angle adjustment for tool holder (16‑40°), fast micropipette replacement;
Thermosafe hot‑air heating system, temperature accuracy better than ±0.1℃, no hot/cold spots;
Integrated 3.5‑inch color touch‑screen, motion‑triggered LED illumination;
Compatible with mainstream inverted microscopes, compact footprint, 40% larger heated stage area;
Optional SAS pneumatic syringe and SOS oil‑filled syringe for pressure control。
4、技术参数 Technical Parameters
表格
| 中文 | English |
|---|---|
| 精细调节：X/Y/Z 亚微米分辨率，X/Y 行程 1.0mm，Z 轴行程 5mm | Fine control: X/Y/Z sub‑micron resolution; X/Y travel 1.0 mm; Z travel 5 mm |
| 粗调节：X/Y 分辨率 10µm，X/Y 行程 4mm | Coarse control: X/Y resolution 10 µm; X/Y travel 4 mm |
| 持针器角度调节范围：16°‑40° | Pipette holder angle:16°‑40° |
| 温控精度：优于 ±0.1℃，分辨率 0.1℃ | Temperature accuracy: better than ±0.1℃, resolution 0.1℃ |
| 热台 XY 移动行程：40mm | Heated stage XY travel:40 mm |
| 供电：100‑240VAC，50‑60Hz，最大 1.8A | Power supply:100‑240VAC,50‑60Hz,max 1.8A |
| 整机尺寸（不含显微镜）：宽 56cm，深 38cm | Dimension(w/o microscope):W56 cm × D38 cm |
| 显微镜安装组件重量：10.4kg | Weight of microscope‑mounted assembly:10.4 kg |
| 接口：USB‑B，可连接 RI‑Viewer 软件 | Interface:USB‑B for RI‑Viewer software connection |
| 工作环境温度：15℃‑40℃ | Operating ambient temperature:15℃‑40℃ |
5、使用方法 Operating Method
中文：
将设备适配安装至倒置显微镜，连接电源、温控系统、注射器管路；
开机，触控屏设置目标工作温度，待热台温度稳定；
将持卵针、注射针安装至持针器，完成管路压力平衡校准；
粗调手柄快速将微针移动至培养皿视野内；细调手柄完成微米级定位；
操作注射器，负压固定卵子，实施精子注射等显微操作；
可按需启动计时、计数功能，外接电脑采集图像视频；
操作结束，关闭温控、主机电源，清洁设备表面，收纳管路配件。English：
Mount device onto inverted microscope; connect power supply, heating system and syringe tubing;
Power‑on, set target temperature via touch‑screen and wait for thermal stabilization;
Install holding pipette and injection pipette into holders, perｆorm tubing pressure equilibration calibration;
Use coarse joystick to bring pipettes into dish view; fine joystick for micron‑level positioning;
Operate syringes: apply negative pressure to hold oocytes and perｆorm sperm injection;
Activate stop‑watch / counter as needed; connect PC for image and video acquisition;
After procedure: turn off heating and main power, clean device surface and store accessories。
6、适应症 Indications
中文：用于临床机构体外辅助生殖实验室，在显微镜下定位微型操作工具，同时维持样本温度；用于 ICSI 胞浆内单精子注射等体外生殖细胞显微操作，适用于人类辅助生殖临床操作。English：Used in clinical assisted reproductive laboratories. It positions micro‑tools under microscope and maintains sample temperature for ICSI and other in‑vitro germ‑cell micromanipulation in human assisted reproduction。
7、禁忌症 Contraindications
中文：本设备无直接对人体操作，无绝对人体禁忌症；禁止用于非体外辅助生殖目的的人体细胞以外临床侵入操作；不可直接接触人体组织。English：This equipment does not perｆorm direct human‑body intervention, no absolute human contraindications. Forbidden for clinical invasive operations other than assisted‑reproduction in‑vitro cell manipulation; shall not directly contact human tissues.
8、注意事项 Precautions
中文：
经培训的辅助生殖实验室专业人员使用；
定期校验温控系统，温度偏差会损伤生殖细胞；
玻璃微针为耗材，安装、调节时防止破碎划伤；
注射器管路定期检查，防止泄漏、堵塞；每次使用前执行压力平衡；
ITO 加热玻璃插件易碎，搬运清洁小心操作；
设备不可高压灭菌，仅做表面清洁消毒；
避免震动、阳光直射，远离电磁干扰源；
出现温度异常、运动卡顿立即停机检修，不可带故障开展实验；
仅可使用原厂配件及兼容微吸管，禁止改装设备；
USB 外接电脑需满足 IEC60950‑1 安全标准。English：
Only operated by trained ART‑lab professionals;
Calibrate temperature system periodically; temperature deviation may damage germ‑cells;
Glass micropipettes are consumables; avoid breakage and injury during installation;
Inspect syringe tubing regularly for leakage / blockage; perｆorm pressure equilibration before each run;
ITO heated glass insert is fragile, handle with care during cleaning and moving;
Cannot be autoclaved; only surface cleaning and disinfection allowed;
Keep away from vibration, direct sunlight and electromagnetic interference;
Stop operation immediately for abnormal temperature or stuck movement; do not run experiments with faulty equipment;
Use only original accessories and compatible pipettes; no unauthorized modification;
External PC via USB shall comply with IEC60950‑1 safety standard。
9、存储条件 Storage Conditions
中文：环境温度‑10℃~55℃；相对湿度 10%‑80%，无冷凝；避免粉尘、腐蚀性气体、剧烈震动；存放于干燥避光室内，管路、配件妥善收纳。长期闲置前清洁设备，断开电源。English：Ambient temperature:‑10℃~55℃; relative humidity:10%‑80%, non‑condensing. Keep away from dust, corrosive gas and heavy vibration. Store in dry and shaded indoor space; store tubing and accessories properly. Clean device and disconnect power for long‑term storage.
10、说明书核心信息 Core Inｆormation of Instructions
中文： 产品名称：体外辅助生殖用显微操作仪 型号：Integra 3 注册人：瑞思驰医疗设备有限公司（Research Instruments Ltd，英国） 注册证：国械注进 20202180209 结构组成：操作台底盘、嵌入式热台、加热载物台、热风系统（选配）、2 套显微操作器、持针器、调节支架、手托、气压注射器、管路、电源适配器。 预期用途：体外辅助生殖中显微镜下定位微型工具，维持样本温度，供临床机构辅助生殖实验室使用。 分类：Ⅱ 类医疗器械；非无菌，不可高压灭菌；仅实验室体外操作，不直接接触人体。 警示：必须由受过专业培训人员操作；定期温度校准；压力平衡是 ICSI 操作关键步骤；玻璃微针属于耗材，定期更换；故障不得继续使用，联系原厂售后维修。
English： Product Name：Micromanipulation System for In‑vitro Assisted Reproduction Model：Integra 3 Registrant：Research Instruments Ltd (UK) Registration No.：国械注进 20202180209 Components：Base chassis, integrated heated stage, hot‑air heating system (optional), two micromanipulator units, pipette holders, adjustment stands, hand‑rests, pneumatic syringes, tubing, power adapter. Intended use：Position micro‑tools under microscope and maintain sample temperature for clinical assisted‑reproduction laboratories. Classification：Class Ⅱ medical device; non‑sterile, non‑autoclavable; for in‑vitro laboratory use only, no direct human‑tissue contact. Warnings：Operated only by specially‑trained personnel; perｆorm regular temperature calibration; pressure equilibration is critical for ICSI; glass micropipettes are consumables and shall be replaced periodically; stop use upon malfunction and contact manufacturer service。
免责声明：以上产品详情仅供参考，临床操作请以原厂纸质说明书为准。上海康世达医疗器械有限公司不生产医疗产品，所有产品均来自产品的生产厂家，代理商，经销商，如有侵权请联系我们，会尽快处理！The above product details are for reference only. All clinical operations shall be carried out in strict accordance with the original paper instructions for use issued by the manufacturer.
Shanghai Kangshida Medical Devices Co., Ltd. does not manufacture medical devices. All products are sourced from respective manufacturers, authorized agents and distributors.
Please contact us promptly in case of any infringement, and we will resolve the matter as soon as possible.
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