厂家供应巴德医用控温毯317-00C,317-03C,317-05C
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厂家供应巴德医用控温毯317-00C,317-03C,317-05C
桂经理19117326863微xin同号
管理类别
第二类
型号规格
317-00C、317-03C、317-05C、317-07C、317-09C、317-00-04C、317-03-02C、317-05-02C、317-07-02C、317-09-02C、317-02C、317-02-02C、318-01C、318-01-04C、318-02C、318-02-02C
巴德 Arctic Sun 5000 控温仪317系列控温毯（ArcticGel™ Pads）
1. 317-00C（全身通用型）
2. 317-03C（上半身/躯干型）
3. 317-05C（下肢/腿部型）
巴德317系列控温毯（ArcticGel）参数对比表
适配主机：Arctic Sun 5000 医用控温仪
1. 317-00C 全身毯
• 类型：全身标准毯
• 覆盖部位：全身（躯干+四肢）
• 适用：成人全身降温/升温、亚低温治疗
• 特点：大面积全覆盖，水循环均匀
2. 317-03C 上半身毯
• 类型：上半身专用
• 覆盖部位：胸部、躯干、上肢
• 适用：上半身重点控温，心肺、脑部术后等
• 特点：贴合躯干，不影响下肢操作
3. 317-05C 下肢毯
• 类型：下肢专用
• 覆盖部位：双腿、下肢
• 适用：下肢缺血、术后保温、全身辅助控温
• 特点：双侧腿部包裹，穿戴方便
结构及组成/主要组成成分
该产品由垫子、歧管、水管、绝缘套管和接头组成。
适用范围/预期用途
医用控温毯与医用控温仪(型号：5000、6000）配合使用，用于医疗机构中成人和儿童的物理降温、升温以及体温保持。
工作原理 (Working Principle)
中文与 Arctic Sun 5000 主机配合，采用负压水循环 + 专利水凝胶热交换技术。循环水经主机制冷 / 制热后，通过负压管路均匀流经毯内微通道，与三层水凝胶层充分接触；凝胶紧贴患者皮肤，实现高效热交换。系统实时采集患者核心体温，自动调节水温与流量，维持目标体温稳定。EnglishWorks with the Arctic Sun 5000 main unit via negative-pressure water circulation & patented hydrogel heat exchange. Temperature-controlled water flows uniｆormly through micro-channels via negative pressure, exchanging heat efficiently with the 3-ｌayer hydrogel that conｆorms to the patient’s skin. Core temperature is monitored in real time to auto-adjust water temperature/flow for stable target 体温.
二、产品功能 (Functions)
中文
控温：适配 32℃～38.5℃目标体温管理（TTM），支持降温 / 复温双模式。
多尺寸全覆盖：
317-00C：通用型，覆盖成人全身体表
317-03C：中型，适配躯干 / 四肢局部治疗
317-05C：小型，用于头部 / 关节局部控温
智能联动：与主机自动对齐，实现闭环控温、趋势图显示、异常报警。
安全防漏：负压循环 + 密封结构，杜绝漏水；一次性使用避免交叉感染。
数据兼容：配合主机完成治疗数据记录、导出与追溯。
English
Precise TTM: Supports 32°C–38.5°C for hypothermia induction/rewarming.
Multi-Size Coverage:
317-00C: Universal for full-body adult use
317-03C: Medium for torso/limb regional therapy
317-05C: Small for head/joint targeted cooling
Smart Integration: Auto-matches with main unit for closed-loop control, trending, and alarms.
Leak-Proof Safety: Negative-pressure & sealed design; single-use to prevent infection.
Data Compatibility: Works with main unit for data logging/export.
三、产品特点 (Product Features)
中文
专利水凝胶：三层结构，高贴合性、热交换效率高，不压伤皮肤。
水电分离：毯内无裸露电路，安全可靠。
无乳胶 / 无金属：放射可透，适配影像检查；不含乳胶防过敏。
不塌陷结构：承压不变形，保证水流与温度均匀。
即连即用：免组装，与主机快速对接，简化流程。
临床一致：与 Arctic Sun 5000 系统高度兼容，经 ISO 13485 认证。
English
Patented Hydrogel: 3-ｌayer design for high skin conｆormity & efficient heat exchange.
Water-Electric Separation: No exposed circuits for enhanced safety.
Latex/Metal-Free: Radiolucent for imaging; latex-free to reduce allergy risks.
Non-Collapsing: Maintains shape under load for uniｆorm temp/flow.
Plug-and-Play: Quick connection to main unit for simplified workflow.
Clinically Validated: ISO 13485-compliant, fully compatible with Arctic Sun 5000.
四、技术参数 (Technical Specifications)
表格
参数项 (Item) 中文 (Chinese) 英文 (English)
型号 (Model) 317-00C/03C/05C 317-00C/03C/05C
适配系统 Arctic Sun 5000 医用控温仪 Arctic Sun 5000 Temperature Management System
工作温度 与主机一致：4℃～42℃水温，32℃～38.5℃目标体温 Matches main unit: 4°C–42°C water temp, 32°C–38.5°C target
尺寸 (Dimensions) 317-00C：约 101×203cm；03C：约 60×120cm；05C：约 40×80cm 317-00C: ~101×203cm; 03C: ~60×120cm; 05C: ~40×80cm
材质 (Material) 三层水凝胶 + TPU 管路，无乳胶 / 金属 3-ｌayer hydrogel + TPU tubing; latex/ｍmbedl-free
使用方式 一次性使用（单患者） Single-patient use only
连接方式 主机专用接口，负压循环 Dedicated main unit port, negative-pressure circulation
放射特性 放射可透（Radiolucent） Radiolucent
认证 (Certifications) CE, FDA, NMPA, ISO 13485 CE, FDA, NMPA, ISO 13485
五、使用方法 (Instructions for Use)
中文
准备：检查包装完好，取出控温毯；连接主机接口与水管，确认无弯折、漏液。
患者体位：平铺毯体于病床，无褶皱；317-05C 贴合头部 / 患处，确保与皮肤紧密接触。
参数设置：主机设定目标体温、模式（降温 / 复温）、报警阈值。
启动与监测：开机后实时观察体温曲线、水温与流量，每 20 分钟检查探头固定与毯位。
结束处理：按主机停止键，断开连接；丢弃毯体按医疗废物处理；清洁主机。
English
Preparation: Inspect packaging; connect to main unit & check for kinks/leaks.
Patient Placement: Lay flat without wrinkles; 317-05C for head/affected area.
Settings: Enter target temp, mode, and alarms on the main unit.
Start & Monitor: Power on; track trends & check probe/pad position every 20 mins.
Completion: Stop on main unit; disconnect; dispose as medical waste; clean main unit.
六、适应症 (Indications)
中文
心脏骤停后亚低温治疗、急性脑卒中 / 颅脑损伤脑保护。
中枢性高热、难治性高热的物理控温。
围手术期体温维持、术后复温与康复。
新生儿 / 儿童高热、特殊人群（如角膜异常患者）体温管理。
English
Post-cardiac arrest hypothermia, acute stroke/TBI neuroprotection.
Central/refractory hyperthermia physical control.
Perioperative normothermia & post-op rewarming.
Neonatal/pediatric hyperthermia; non-invasive TTM for special populations.
七、禁忌症 (Contraindications)
中文
绝对禁忌：眼球破裂、开放性眼外伤；大面积皮肤破损 / 感染；对水凝胶过敏。
相对禁忌：严重凝血功能障碍、活动性出血；不可控休克；孕妇；角膜极薄 / 极厚患者。
English
Absolute: Ruptured globe; open eye trauma; broken/infected skin; hydrogel allergy.
Relative: Severe coagulopathy/active bleeding; irreversible shock; pregnancy; extremely thin/thick cornea.
八、注意事项 (Precautions)
中文
医护人员操作，严格按说明书执行。
毯体一次性使用，严禁复用；避免尖锐物刺破。
必须与 Arctic Sun 5000 主机配套使用，非兼容设备可能导致控温失效。
温度探头需固定牢固，每 20 分钟检查移位；每小时观察皮肤状况。
禁止酒精接触毯体，清洁仅用中性清洁剂。
治疗中密切监测报警（缺水、超温、探头脱落），及时处理。
English
Trained staff only; follow instructions strictly.
Single-patient use only; no reuse; avoid sharp punctures.
Use only with Arctic Sun 5000; non-compatible units may fail.
Secure probe; check every 20 mins; skin check hourly.
No alcohol on pad; clean with neutral detergent only.
Monitor alarms (low water, overtemp, probe disconnect) promptly.
九、存储条件 (Storage Conditions)
中文
温度：-10℃～+55℃（存储）；+10℃～+35℃（操作）。
湿度：10%～95% RH，无冷凝。
环境：干燥、清洁、通风，远离腐蚀气体、火源与强磁场。
存放：原包装密封，防震防潮，避免阳光直射。
运输：-40℃～+70℃，防震包装，避免剧烈碰撞。
English
Temp: -10°C to +55°C (storage); +10°C to +35°C (operation).
Humidity: 10–95%RH, non-condensing.
Environment: Dry, clean, ventilated; away from corrosives, fire, EMI.
Storage: Sealed in original packaging; shock/moisture-proof.
Transport: -40°C to +70°C; shockproof packaging.
十、说明书核心信息 (Manual Core Inｆormation)
中文
产品分类：二类医疗器械（与 Arctic Sun 5000 主机配套）。
制造商：美国 Medivance, Inc.（现 BD）。
规格：317-00C（通用）、317-03C（中型）、317-05C（小型）。
组成：控温毯主体、连接水管、独立包装。
执行标准：ISO 13485, IEC 60601-1/-2, FDA 510(k)。
有效期：未开封包装内，按包装标注有效期。
使用限制：Rx 仅，医疗机构内专业人员使用。
废弃处理：按医疗废物规范分类处置。
English
Classification: Class II medical device (for Arctic Sun 5000).
Manufacturer: Medivance, Inc. (now BD), USA.
Sizes: 317-00C (Universal), 317-03C (Medium), 317-05C (Small).
Components: Pad, tubing, individually wrapped.
Standards: ISO 13485, IEC 60601-1/-2, FDA 510(k).
Shelf Life: As labeled in unopened packaging.
Restriction: Rx only; for hospital use by trained professionals.
Disposal: Comply with medical waste regulations.
Shanghai Kangshida Medical Devices Co., Ltd. is a professional company engaged in the sales of medical devices, focusing on the agency and distribution of renowned medical equipment brands from both domestic and international markets. Its core product range covers full-scenario medical devices for physical examination, diagnosis, emergency treatment, laboratory testing, ultrasound, medical analysis, life sciences, disinfection and sterilization, rehabilitation therapy, operating rooms, emergency rooms, consulting rooms and other fields. Relying on its strong product sales capacity, excellent commercial reputation and integrity-based operation philosophy, the company has won unanimous recognition and trust from medical institutions and partners.
The steady and rapid development of the company is attributed to its carefully selected high-quality product portfolio. It always takes customer needs as the core orientation and is committed to creating long-term value and practical benefits for customers. As an authorized and exclusive agent for many well-known domestic and international manufacturers, the company has established a complete supply system of medical devices with reliable quality, fully meeting the needs of clinical diagnosis and treatment.
The company always takes improving customer satisfaction as its core goal. To strictly adhere to product standards and exceed the expectations of customers and manufacturers, it regularly provides training on professional ethics and professional business skills, forging a highly competent, efficient and executive team covering business, technology and management. The team implements a 7×24-hour all-weather response mechanism to provide professional and high-quality after-sales service and technical support, efficiently solving various equipment operation and maintenance problems. At the same time, the company offers exclusive services including same-day delivery and free distribution, ｆorming a closed loop covering supply, distribution and after-sales service to fully ensure the stable supply and worry-free use of medical equipment for medical institutions.
Upholding integrity as the foundation of its business, the company selects high-quality medical devices and provides professional services for customers, helping to upgrade the quality of medical services and contributing to the high-quality development of China's medical industry.
Intellectual Property Infringement Complaint: Kangshida Medical does not manufacture medical products; all products are sourced from original manufacturers. We will promptly address any intellectual property infringement issues.The content published herein is for reference only.
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