厂商供应伟伦一次性阴道扩张器58000S,58001S
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厂商供应伟伦一次性阴道扩张器58000S,58001S
桂经理19117326863微xin同号
产品名称
一次性阴道扩张器Single Use Vaginal Speculum
管理类别
第二类
型号规格
58000S, 58001S, 58004S, 58600, 58601, 590XS, 59000, 59001, 59004, 59005, 59006
结构及组成/主要组成成分
主要由上叶、下叶和手柄组成。
适用范围/预期用途
用于在骨盆检查和其他妇产科处置过程中扩张阴道，使内阴道和外子宫颈暴露出来。
一、工作原理（Working Principle）
中文
采用物理机械扩张 + 光学可视原理：
机械扩张：由上叶、下叶与调节手柄组成鸭嘴式双叶结构。通过按压 / 推动手柄调节机构，带动上叶向上张开，利用卡齿锁止结构固定扩张角度，物理撑开阴道壁，暴露阴道与宫颈。
光学辅助：透明高透光材质确保全视野无遮挡；配套一体式光源护套，可适配伟伦光纤 / LED 光源系统，光线均匀投射至检查区域，提升内部组织清晰度。
无菌防护：一次性独立设计，避免复用导致交叉感染；护套可包裹光源线缆，隔绝体液污染。
English
Based on mechanical expansion & optical visualization:
Mechanical Expansion: Duckbill dual-blade structure (upper/lower blades + handle). Squeezing/pushing the handle opens the upper blade; ratchet lock fixes the angle to physically distend the vaginal wall, exposing the vagina and cervix.
Optical Aid: Clear, high-transparency acrylic for unobstructed viewing; integrated light sheath fits Welch Allyn fiber optic/LED systems, projecting uniｆorm light for clear tissue visualization.
Infection Control: Single-use, disposable design eliminates cross-contamination; sheath covers light cord to block fluid contamination.
二、产品功能（Functions）
中文
阴道扩张暴露：撑开阴道壁，清晰暴露阴道壁、宫颈口、宫颈，满足检查视野需求。
光源适配：带一体式护套，适配伟伦 78800/78900 系列光纤 / LED 光源，提供均匀照明。
角度锁定：多档位卡齿锁止，固定扩张角度，解放医护双手。
防污染防护：护套包裹光源线缆，隔绝体液、分泌物，降低设备污染。
尺寸适配：58000S（小号）→ 幼女、绝经后、子宫切除后女性；58001S（中号）→ 成年女性常规检查。
一次性使用：无菌 / 非无菌可选，即用即弃，无需清洗消毒。
English
Vaginal Distention: Spreads vaginal walls to clearly expose vaginal mucosa, cervix, cervical os for examination.
Light Compatibility: Integrated sheath fits Welch Allyn 78800/78900 fiber optic/LED light sources for uniｆorm illumination.
Angle Lock: Multi-position ratchet secures opening, freeing clinician’s hands.
Contamination Barrier: Sheath covers light cord to block fluids/secretions, protecting equipment.
Size Matching: 58000S (Small) → pediatric/post-menopausal/hysterectomy patients; 58001S (Medium) → routine adult exams.
Single-Use: Sterile/non-sterile options; discard after use, no reprocessing.
三、产品特点（Product Features）
中文
医用级透明材质：高纯度丙烯酸（Acrylic），透明无杂质，视野清晰；光滑无毛刺，避免划伤黏膜、减少组织挤压 / 粘连。
人体工学设计：加宽防滑手柄，握持稳定、操控省力；前短后长叶片，贴合阴道解剖结构，降低牵拉不适。
稳固锁止系统：卡齿档位，扩张角度稳定不打滑、不回弹。
一体式光源护套：预安装护套，快速下拉包裹光源线，防污染、操作高效。
尺寸规格清晰：颜色标识手柄（58000S 绿 / 58001S 蓝），快速区分尺寸。
安全可靠：高抗变形强度，使用中不易断裂；一次性无菌包装（可选），降低感染风险。
高效经济：即用即弃，省去金属扩张器清洗、消毒、维护成本。
English
Medical-Grade Clarity: High-purity clear acrylic for unobstructed view; smooth, burr-free to prevent mucosal scratches & tissue pinching.
Ergonomic Design: Wide, non-slip handle for stable grip; anterior-short/posterior-long blades fit vaginal anatomy, reducing discomfort.
Secure Locking: Precision ratchet positions hold firmly, no slipping/rebound.
Integrated Light Sheath: Pre-attached sheath quickly covers light cord, contamination-proof & efficient.
Color-Coded Sizing: Color-coded handles (58000S=green / 58001S=blue) for instant size ID.
Safe & Durable: High deｆormation resistance; sterile packaging (optional) reduces infection risk.
Cost-Effective: Single-use eliminates reprocessing labor/costs vs. ｍmbedl specula.
四、技术参数（Technical Specifications）
表格
参数项 (Parameter) 58000S (小号 / Small) 58001S (中号 / Medium) 英文 (English)
型号 58000S 58001S 58000S / 58001S
类型 双叶鸭嘴式（Pederson） 双叶鸭嘴式（Pederson） Dual-bladed Duckbill (Pederson)
材质 医用透明丙烯酸 医用透明丙烯酸 Medical-grade clear acrylic
尺寸 小号（Small） 中号（Medium） Small / Medium
手柄标识 绿色 蓝色 Green / Blue Handle
光源适配 伟伦 78800/78900 光纤 / LED 伟伦 78800/78900 光纤 / LED Welch Allyn 78800/78900 Light Systems
锁止结构 多档位卡齿 多档位卡齿 Multi-position ratchet lock
无菌状态 非无菌（可环氧乙烷灭菌） 非无菌（可环氧乙烷灭菌） Non-sterile (EO-sterilizable)
包装规格 18 个 / 盒，4 盒 / 箱 18 个 / 盒，4 盒 / 箱 18/box, 4 boxes/case
使用方式 一次性使用 一次性使用 Single-use only
注册认证 国械注进 20172187053、CE 国械注进 20172187053、CE FDA, CE, China Drug Registration
五、使用方法（Operation Method）
中文
准备
检查包装：完好无破损，确认型号 / 尺寸 / 有效期。
无菌操作：无菌区打开包装，戴无菌手套；非无菌检查可直接取用。
光源准备：将伟伦光源线插入护套入口，下拉护套包裹线缆。
润滑：无菌水溶性润滑剂涂抹扩张器前端（避宫颈口）。
置入
患者：膀胱截石位，放松会阴。
分开小阴唇，闭合状态下扩张器 ** 倾斜 45°** 缓慢插入阴道，深度至宫颈后方。
缓慢向上旋转至水平，轻轻推动 / 按压手柄，上叶缓慢张开至暴露宫颈。
卡齿自动锁止固定角度，进行检查 / 操作。
结束
松止键，缓慢闭合叶片。
沿置入角度平稳退出扩张器。
立即丢弃至医疗废物容器。
清洁光源线，整理设备。
English
Preparation
Inspect package: intact, undamaged; verify size/expiry.
Aseptic technique: open in sterile field, sterile gloves; non-sterile use: direct handling.
Light setup: insert light cord into sheath, pull sheath down to cover cord.
Lubrication: apply sterile water-based lubricant to tip (avoid cervical os).
Insertion
Patient: lithotomy position, relaxed perineum.
Separate labia; insert closed speculum at 45° slowly into vagina until deep enough.
Rotate to horizontal; squeeze/push handle to open upper blade until cervix is visible.
Ratchet locks automatically to hold position.
Completion
Release ratchet; close blades slowly.
Withdraw smoothly at insertion angle.
Discard immediately in medical waste.
Clean light cord & store equipment.
六、适应症（Indications）
中文
妇科常规盆腔检查：阴道壁、宫颈外观、色泽、分泌物、病变筛查。
细胞学采样：TCT/HPV、巴氏涂片宫颈细胞取样。
阴道内操作：阴道上药、息肉摘除、活检、异物取出。
术前 / 术后检查：妇科手术术前评估、术后复查。
特定人群：58000S → 幼女、绝经后、子宫切除后女性；58001S → 成年女性常规检查。
English
Routine Gynecologic Exam: Screen for vaginal/cervical lesions, discharge, abnormalities.
Cytologic Sampling: TCT/HPV, Pap smear collection.
Vaginal Procedures: Medication application, polypectomy, biopsy, foreign body removal.
Pre/Post-Op: Gynecologic surgery pre-op assessment, post-op follow-up.
Special Populations: 58000S → pediatric, post-menopausal, post-hysterectomy; 58001S → routine adult exams.
七、禁忌症（Contraindications）
中文
绝对禁忌
阴道急性炎症 / 感染（滴虫、霉菌、细菌性阴道炎急性期）。
阴道活动性出血（经期、创伤、术后大出血、不明原因出血）。
阴道畸形、闭锁、严重狭窄无法安全置入。
外阴 / 阴道严重损伤、烧伤、溃疡。
患者极度恐惧、不配合、无法耐受检查。
相对禁忌
宫颈癌晚期、阴道恶性肿瘤（避免操作导致出血 / 扩散）。
妊娠期（尤其早 / 晚期，需严格评估后谨慎使用）。
English
Absolute Contraindications
Acute vaginal infection/inflammation (active trichomonas, candidiasis, bacterial vaginosis).
Active vaginal bleeding (menses, trauma, post-op hemorrhage, unknown bleeding).
Vaginal malｆormation, atresia, severe stenosis preventing safe insertion.
Severe vulvar/vaginal injury, burns, ulcers.
Severe patient fear, uncooperative, intolerant.
Relative Contraindications
Advanced cervical/vaginal cancer (risk of bleeding/spread).
Pregnancy (1st/3rd trimesters: use only after strict evaluation).
八、注意事项（Precautions）
中文
使用前
严禁复用：一次性产品，一人一用一废弃。
包装破损、污染、过期、变形、裂纹禁止使用。
选择合适尺寸：过小视野不足；过大致疼痛 / 损伤。
仅用水溶性润滑剂，禁用凡士林 / 油类（损伤材质、破坏乳胶）。
使用中
动作轻柔，禁止暴力插入 / 扩张，避免黏膜撕裂。
置入遇阻力立即停止，排查原因（畸形、痉挛、病变）。
锁止适度，勿过度扩张致疼痛、缺血、损伤。
检查中密切观察患者反应，出现剧痛、出血立即停止。
使用后
按医疗废物规范处理，严禁随意丢弃。
光源线及时清洁消毒，防止交叉污染。
English
Before Use
Single-use only: one patient, one use, one discard.
Do NOT use if damaged, contaminated, expired, deｆormed, cracked.
Correct size selection: too small = poor view; too large = pain/injury.
Water-based lubricant only; no petrolatum/oils (damages material).
During Use
Gentle technique only; no forceful insertion/expansion.
Stop immediately on resistance; investigate (malｆormation, spasm, lesion).
Lock moderately; over-distention causes pain, ischemia, injury.
Monitor patient closely; stop for severe pain/bleeding.
After Use
Dispose per medical waste regulations.
Clean/disinfect light cord to prevent cross-contamination.
九、存储条件（Storage Conditions）
中文
温度：-20℃ ~ +49℃（-4℉ ~ 120℉）。
湿度：15% ~ 95% RH（无冷凝）。
环境：干燥、清洁、通风；远离高温、潮湿、阳光直射、腐蚀性气体、尖锐物、化学试剂。
存放：原包装内平放；避免挤压、堆叠、重压；避光保存。
有效期：详见包装标识；过期严禁使用。
English
Temperature: -20°C ~ +49°C (-4°F ~ 120°F).
Humidity: 15% ~ 95% RH (non-condensing).
Environment: Dry, clean, ventilated; away from heat, moisture, direct sunlight, corrosives, sharp ｏbjects, chemicals.
Storage: Store flat in original packaging; no crushing, heavy stacking; protect from light.
Expiry: See label; do NOT use expired product.
十、说明书核心信息（Manual Core Inｆormation）
中文
产品名称：伟伦 KleenSpec? 58000S/58001S 一次性阴道扩张器
生产厂家：Welch Allyn, Inc.（美国，Hillrom 旗下）
结构：上叶、下叶、调节手柄、卡齿锁、一体式光源护套
材质：医用透明丙烯酸（Acrylic）
规格：58000S（小号 / 绿柄）、58001S（中号 / 蓝柄）
灭菌：非无菌（可 EO 灭菌）
使用：一次性使用，严禁复用
适应症：妇科盆腔检查、宫颈采样、阴道操作
禁忌症：急性炎症、活动性出血、阴道畸形、严重损伤
关键警告
专业医护人员操作
一人一用一废弃，防交叉感染
禁止暴力操作，避免组织损伤
过期 / 破损产品严禁使用
仅水溶性润滑剂，禁用油类
English
Product Name: Welch Allyn KleenSpec? 58000S/58001S Disposable Vaginal Speculum
Manufacturer: Welch Allyn, Inc. (USA, Hillrom)
Structure: Upper/lower blades, handle, ratchet lock, integrated light sheath
Material: Medical-grade clear acrylic
Sizes: 58000S (Small, green) / 58001S (Medium, blue)
Sterility: Non-sterile (EO-sterilizable)
Usage: Single-use only; DO NOT REUSE
Indications: Gynecologic exam, cervical sampling, vaginal procedures
Contraindications: Acute infection, active bleeding, malｆormation, severe injury
Key Warnings
For professional use only
One patient/one use/discard; prevent cross-contamination
Gentle technique only; avoid tissue trauma
Do NOT use expired/damaged product
Water-based lubricant only; no oils/petrolatum
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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