Interface and function review接口与功能确认
A medical-material label does not establish finished-assembly compliance材料医用标签不能证明成品组件合规
Medical Project Cable医疗项目电缆
ECG Multi-Lead HarnessECG心电多导联线束
ECG Multi-Lead Harness can be configured around equipment interfaces and routing. Equipment risk control, applied parts, signals, cleaning, usability and traceability define the cable.ECG心电多导联线束可围绕设备接口与安装路径进行配置。设备风险控制、应用部分、信号、清洁、可用性与追溯共同定义线缆。
- Interface and circuit review接口与回路对应审核
- Length and installation configuration线长与安装结构定制
- Manufacture from approved sample样品确认后组织制造
CONSTRUCTION结构解析
Conductor, insulation and material choices导体、绝缘与选材要点
Use the ecg multi-lead harness form as a starting point and confirm these design points against drawings and the actual equipment.以ECG心电多导联线束的结构形式为起点，结合图纸和实际设备确认以下设计要点。
Installation and acceptance安装与验收
Confirm sterilization, disinfection and wipe conditions separately灭菌、消毒和擦拭条件分别确认
Manufacturing reference制造依据
Confirm drawings, circuit mapping, dimensional datums and sample revision before manufacture to control fit checks and repeat production.确认图纸、连接关系、尺寸基准和样品版本后再制作，减少试装与重复生产中的差异。
CONFIGURATION结构与选配
Construction & customization options结构与定制配置
The table describes the construction and available configuration choices. Materials, dimensions, circuits and inspection requirements are agreed for each project.以下说明展示结构与可配置内容。具体材料、尺寸、电路和检验要求按项目确认。
| Internal-device or patient-contact use医疗设备内部或患者接触用途 | Define actual internal, external or patient-contact use.说明设备内部、外部或患者接触的实际用途。 |
|---|---|
| Skin-contact duration and cleaning/disinfection media皮肤接触时间与清洁消毒介质 | Define contact duration, cleaning and disinfection agents from equipment requirements.接触时间、清洁和消毒介质须由设备要求确定。 |
| Material grade, flexibility and electrical isolation材料牌号、柔性和电气隔离要求 | Specify material grade, flexibility and electrical isolation separately.材料牌号、柔性与电气隔离分别形成选材条件。 |
| Specific biocompatibility or device-document scope生物相容或设备文件具体范围 | Biocompatibility or equipment documents must identify the component and contact scope.生物相容或设备文件需对应明确组件与接触范围。 |
| Installation and operating boundary安装与使用边界 | Provide equipment boundary, circuits, interface, handling, cleaning and validation plan.请提供设备边界、回路、接口、操作、清洁与验证计划。 |
| Sample and release basis样品与放行依据 | Release records component identity, process, inspection and traceability.放行记录包含元件身份、工艺、检验与追溯。 |
APPLICATIONS连接的应用
Application directions应用方向
These are connection directions for project discussion. Suitability depends on interfaces, circuits, installation conditions and project validation; configuration can be adapted to the equipment.以下为可讨论的连接方向。实际适用性取决于接口、电路、安装环境和项目验证，可按设备需求调整。
Module wiring within enclosures机箱内部的模块配线
Coordinate board positions, module removal and wire bends within the enclosure. Preserve insulation clearance and support behind each termination. Define actual internal, external or patient-contact use.机箱内部配线需要协调板卡位置、模块拆装和导线转弯空间；端接后的绝缘与支撑不能被外壳挤压。选配时，说明设备内部、外部或患者接触的实际用途。
Instrument connections in medical equipment医疗设备的仪器连接
Define internal or external location, actual contact boundaries and cleaning conditions before selecting materials, flexibility and validation plans. Define contact duration, cleaning and disinfection agents from equipment requirements.设备连接应明确内部或外部位置、实际接触边界和清洁条件，再确定材料、柔性及验证计划。选配时，接触时间、清洁和消毒介质须由设备要求确定。
Module connections in laboratory equipment实验室设备的模块配线
Coordinate sample areas, moving mechanisms and serviceable modules in laboratory equipment. Take isolation and cleaning requirements from the target device documents. Specify material grade, flexibility and electrical isolation separately.实验设备连接需要协调样品区、运动机构和可维护模块，电气隔离与清洁要求应来自目标设备文件。选配时，材料牌号、柔性与电气隔离分别形成选材条件。
Detachable circular connections可拆卸圆形连接
Check gender, keying, coupling and end-face views together. Equal contact counts do not replace confirmation of the exact series and part numbers. Biocompatibility or equipment documents must identify the component and contact scope.圆形接口需要同时核对公母、键位、锁紧方式和端视图，针数相同并不能替代完整系列与料号确认。选配时，生物相容或设备文件需对应明确组件与接触范围。
Equipment control-board connections设备控制板连接
Document pin-row views, mating direction and nearby wire support. Check access to the latch and contacts after assembly. Define actual internal, external or patient-contact use.板端连接要给出针排视图、插合方向和近端线缆支撑；检查装配后是否仍能操作锁扣并查看接点。选配时，说明设备内部、外部或患者接触的实际用途。
Enclosure entries and cable retention机箱穿线与入口固定
Match cable entries to actual diameter, panel thickness and fixing method. Keep jacket retention independent of the internal termination. Define contact duration, cleaning and disinfection agents from equipment requirements.线缆入口需匹配实际外径、板厚和固定方式；护套夹持与内部端接之间应保留独立的支撑路径。选配时，接触时间、清洁和消毒介质须由设备要求确定。
ENGINEERING & PRODUCTION工程与制造
Adapt the connection to your equipment.围绕设备，调整连接细节。
Touched by me, better it’ll beTouched by me, better it’ll be
Custom wire harness manufacturing in China中国工厂 · 定制线束制造
Our China factory supports medical project cable projects through custom wire harness manufacturing and OEM/ODM development. Interface, circuit and installation data guide material selection, sample builds and manufacturing-document approval before repeat production.Super Smile-Tech 中国工厂围绕医疗项目电缆的项目需求提供定制线束制造与 OEM/ODM 支持。我们从接口、电路与安装资料开始，协同物料选配、样品制作和制造文件确认，再按批准要求组织重复生产。
Define conductors and layer construction定义导体与层结构
Define actual internal, external or patient-contact use. A medical-material label does not establish finished-assembly compliance.说明设备内部、外部或患者接触的实际用途。 材料医用标签不能证明成品组件合规。
Match the actual installation duty匹配实际敷设工况
Define contact duration, cleaning and disinfection agents from equipment requirements. Confirm sterilization, disinfection and wipe conditions separately.接触时间、清洁和消毒介质须由设备要求确定。 灭菌、消毒和擦拭条件分别确认。
Confirm material and inspection documents确认材料与检验文件
Specify material grade, flexibility and electrical isolation separately. The device designer must define patient-contact boundaries.材料牌号、柔性与电气隔离分别形成选材条件。 患者接触边界需由设备设计方确定。
PRODUCT QUESTIONS产品问答
Product & customization questions产品与定制常见问题
Does a medical-material label establish finished-assembly compliance?医用材料标签能证明成品合规吗？
A medical-material label does not establish finished-assembly compliance. Define actual internal, external or patient-contact use.材料医用标签不能证明成品组件合规。说明设备内部、外部或患者接触的实际用途。
Are sterilization, disinfection and wiping the same condition?灭菌、消毒和擦拭可以作为同一条件吗？
Confirm sterilization, disinfection and wipe conditions separately. Define contact duration, cleaning and disinfection agents from equipment requirements.灭菌、消毒和擦拭条件分别确认。接触时间、清洁和消毒介质须由设备要求确定。
Who defines the patient-contact boundary?谁确定患者接触边界？
The device designer must define patient-contact boundaries. Specify material grade, flexibility and electrical isolation separately.患者接触边界需由设备设计方确定。材料牌号、柔性与电气隔离分别形成选材条件。
Start with your interface and installation requirements从您的接口与安装需求开始
Share mating interfaces, a circuit table, target lengths or a sample for the ecg multi-lead harness. We can use them to review configuration and sample requirements.提供ECG心电多导联线束的对插接口、回路表、目标长度或参考样品，我们据此梳理选配与样品确认事项。