厂商直销好玛低频电子脉冲治疗仪TENS21
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厂商直销好玛低频电子脉冲治疗仪TENS21
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
TENS21
结构及组成/主要组成成分
产品由治疗仪主机、温热电极和电极绑带所组成。治疗仪频率范围3-1000Hz，误差±10%或±1Hz（两者
取大值）；最大脉冲宽度115µs，偏差±30%；最大输出电流为34mA，偏差±30%；单个脉冲最大输出能
量≤300mJ；最高温度＜43℃。
适用范围/预期用途
通过皮肤对神经以及肌肉进行电刺激，从而达到镇痛和预防或缓解肌肉发生废用性萎缩的效果
一、工作原理 Working Principle
中文
仪器输出调制低频脉冲电流，经温热电极透过皮肤作用于外周神经与骨骼肌。依据闸门控制理论阻断疼痛信号向中枢传导；同时刺激机体释放内啡肽产生镇痛效应；低频电信号促使肌肉节律性收缩，改善局部血液循环，激活神经肌肉通路，预防、改善肌肉废用性萎缩；搭配温热电极升温作用，扩张软组织血管，提升电刺激渗透效果，强化理疗作用。独有脊髓通电疗法，调节自主神经，舒缓紧张、改善循环。
English
The device outputs modulated low-frequency pulsed current, which acts on peripheral nerves and skeletal muscles through thermoelectrodes via the skin. It blocks pain signals transmitted to the central nervous system based on the gate control theory. Meanwhile, it stimulates the body to secrete endorphins for analgesia. Low-frequency electrical signals induce rhythmic muscle contraction, improve local blood circulation, activate neuromuscular pathways, and prevent and relieve disuse muscular atrophy. Combined with thermal electrodes to dilate soft tissue blood vessels, it enhances the penetration of electrical stimulation and physiotherapy efficacy. The exclusive spinal electrotherapy regulates autonomic nerves to relieve tension and improve circulation.
二、产品功能 Functions
中文
经皮神经电刺激镇痛（TENS），缓解急慢性神经源性、肌肉源性疼痛
神经肌肉电刺激（NMS），促进肌肉收缩，防治废用性肌萎缩
温热同步理疗，电极恒温热敷，提升治疗舒适度与疗效
支持脊髓通电疗法，调节自主神经、改善全身血液循环、缓解疲劳
31 套自动预设处方，适配不同部位与病症；支持手动自定义参数
多路独立输出通道，可同时多部位同步治疗；输出强度独立可调
English
Transcutaneous Electrical Nerve Stimulation (TENS) for relief of acute and chronic neurogenic and myogenic pain
Neuromuscular Stimulation (NMS) to promote muscle contraction and prevent disuse muscular atrophy
Synchronized thermal physiotherapy with constant-temperature heating electrodes to improve comfort and curative effect
Spinal electrotherapy to regulate autonomic nerves, improve systemic blood circulation and relieve fatigue
31 built-in automatic preset protocols for different body parts and symptoms; manual parameter customization available
Multiple independent output channels for simultaneous multi-site treatment with separately adjustable intensity
三、产品特点 Product Features
中文
日本原装二类医用设备，31 种标准化自动治疗处方，模式丰富
低频脉冲波形柔和，刺激体感舒适，不易产生刺痛感
集成温热电极，最高温度＜43℃，恒温五档可调，安全性高
多通道独立输出，支持平衡调节，适配两侧肌肉张力不均衡患者
清晰分区操作面板，搭配有线遥控，方便临床操作
连续长时间稳定运行，可持续工作，适合康复科、疼痛科日常诊疗
电极材质柔软可弯曲，贴合关节、脊柱等不规则人体部位
定时治疗功能，1~15 分钟分级设置，避免过度刺激
English
Class II medical device imported from Japan, equipped with 31 standardized automatic treatment protocols with abundant modes
Soft low-frequency pulse waveｆorm brings comfortable stimulation without stinging sensation
Built-in thermoelectrodes with maximum temperature below 43℃, 5 adjustable constant temperature levels with high safety
Multi-channel independent output with balance adjustment for patients with asymmetric muscle tension
Clearly partitioned control panel with wired remote control for convenient clinical operation
Stable long-duration continuous operation, suitable for daily treatment in rehabilitation and pain departments
Flexible bendable electrodes, closely fitting irregular body areas such as joints and spine
Programmable timer (1–15 minutes) to avoid excessive electrical stimulation
四、技术参数 Technical Parameters
中文
型号：TENS21
电源：AC220V，50/60Hz
额定功耗：23W
输出频率：3Hz～1000Hz；自动处方范围 3~245Hz
脉冲最大宽度：115µs
最大输出电流：34mA（峰值 38mA）
单脉冲最大能量：≤300mJ
电极温控：5 档可调，最高温度＜43℃
定时范围：1～15min（逐分钟调节）
输出通道：多路独立通道
整机尺寸：378×280×210mm
整机重量：3.7kg
注册证：国械注进 20162091879
English
Model: TENS21
Power Supply: AC220V, 50/60Hz
Rated Power Consumption: 23W
Output Frequency: 3Hz～1000Hz; automatic protocols: 3~245Hz
Max Pulse Width: 115µs
Max Output Current: 34mA (peak 38mA)
Max Single Pulse Energy: ≤300mJ
Electrode Temperature Control: 5 adjustable levels, maximum temperature ＜43℃
Timer Range: 1～15min (adjustable per minute)
Output Channels: Multiple independent channels
Dimensions: 378×280×210mm
Net Weight: 3.7kg
Registration No.: NMPA Imported Medical Device Registration 20162091879
五、使用方法 Operation Method
中文
将主机放置平稳，接通电源；连接输出导线与温热电极、绑带
清洁治疗部位皮肤，将电极紧密贴合患处，使用绑带固定；电极不可接触破损皮肤
开机，根据病症选择自动处方或手动设置频率、脉冲强度、温度、治疗时长
缓慢上调输出强度，以患者耐受范围内轻微肌肉收缩、无明显刺痛为宜
启动治疗，达到设定时间设备自动停止；治疗过程中询问患者感受，及时调整参数
治疗结束后，先将强度归零，关机，取下电极，清洁电极妥善收纳
脊髓通电模式：电极放置颈段与腰骶段脊柱两侧，严格遵循医师指导摆放位置
English
Place the main unit stably and connect power; link output cables, thermoelectrodes and fixing straps
Clean the skin of treatment area, attach electrodes tightly and fix with straps; avoid damaged skin
Power on, select automatic protocol or manually set frequency, intensity, temperature and treatment duration according to symptoms
Increase output intensity gradually until mild muscle contraction occurs within patient tolerance without obvious stinging
Start treatment; the device will stop automatically upon timeout. Adjust parameters promptly according to patient feedback
After treatment, turn intensity to minimum, power off, remove electrodes, clean and store properly
For spinal electrotherapy mode: place electrodes beside cervical and lumbosacral spine under professional guidance
六、适应症 Indications
中文
通过皮肤对神经以及肌肉进行电刺激，达到镇痛，预防或缓解肌肉废用性萎缩。
临床适用：颈椎病、腰椎间盘病变、周围神经卡压综合征、末梢神经麻痹、脑卒中后遗症肢体功能障碍、各类软组织慢性疼痛、关节劳损、疲劳综合征、神经源性疼痛。
English
Transcutaneous electrical stimulation on nerves and muscles for analgesia, prevention and relief of disuse muscular atrophy.
Clinical applications: Cervical spondylosis, lumbar disc disorders, peripheral nerve entrapment syndrome, peripheral nerve paralysis, limb dysfunction after stroke, chronic soft tissue pain, joint strain, fatigue syndrome, neurogenic pain.
七、禁忌症 Contraindications
中文
佩戴心脏起搏器、植入式除颤器患者严禁使用
恶性肿瘤部位、急性感染、皮肤溃疡、创面、湿疹部位禁止放置电极
出血倾向、血栓急性期患者禁用
孕妇禁止将电极放置于腹部、腰骶部位
严重心律失常、癫痫未控制患者禁用
严禁电极跨心脏摆放；禁止刺激颈动脉窦、眼球、喉头、头部前侧
意识障碍、感觉严重迟钝无法正常反馈感受者，须医师评估后慎用
English
Strictly prohibited for patients with cardiac pacemaker or implantable defibrillator
Do not place electrodes on malignant tumor lesions, acute infection, skin ulcer, wounds or eczema
Contraindicated for patients with bleeding tendency or acute thrombosis
Pregnant women cannot receive stimulation on abdomen and lumbosacral region
Contraindicated for uncontrolled severe arrhythmia and epilepsy patients
Do not place electrodes across the heart; avoid carotid sinus, eyeballs, larynx and anterior head region
Use cautiously for patients with consciousness disorder or severe sensory deficit after physician assessment
八、注意事项 Precautions
中文
仅由医护人员或经培训人员操作，严格按照医嘱选择治疗模式、强度与时长
电极必须完全贴合皮肤，禁止干电极直接接触皮肤，防止灼伤
治疗中如出现灼痛、头晕、心慌，立即停机检查
温热电极温度不可过高，持续监控皮肤状态，防止低温烫伤
不可同时与其他高频手术设备、短波理疗设备共用同一患者
定期清洁电极海绵，保持湿润导电；电极老化及时更换
禁止摔落、撞击主机；避免液体渗入仪器内部
单次治疗不超过 15 分钟，同一部位每日治疗遵循临床规范，不可长时间连续刺激
儿童、糖尿病周围神经病变患者需降低强度，严密监护
English
Operated only by medical staff or trained personnel; select mode, intensity and duration per doctor’s advice
Electrodes must fully adhere to skin; dry electrodes are forbidden to avoid skin burn
Stop treatment immediately if burning pain, dizziness or palpitations occur
Do not set excessive temperature for thermoelectrodes; monitor skin status to prevent low-temperature scald
Do not use together with high-frequency surgical equipment or shortwave physiotherapy device on the same patient
Clean electrode sponge regularly and keep conductive; replace aged electrodes timely
Prevent falling and impact on main unit; avoid liquid infiltration into equipment
Single treatment ≤15 minutes; follow clinical standard for repeated stimulation on the same area
Reduce intensity and strengthen monitoring for children and patients with diabetic peripheral neuropathy
九、存储条件 Storage Conditions
中文
环境温度：5℃～40℃；相对湿度：30%～80%，无凝露；大气压力 700hPa～1060hPa
存放于干燥、通风、无尘室内；避免阳光直射、高温、潮湿、腐蚀性气体。
长期闲置时断开电源，电极清洁晾干后收纳，避免电极海绵长期受压变形。
English
Ambient temperature: 5℃～40℃; Relative humidity: 30%～80%, non-condensing; Atmospheric pressure:700hPa～1060hPa
Store in dry, ventilated and dust-free room; avoid direct sunlight, high temperature, humidity and corrosive gas.
Disconnect power for long-term storage. Clean and air-dry electrodes before storage to prevent sponge deｆormation under long pressure.
十、说明书核心摘要 Manual Core Summary
中文
产品名称：低频电子脉冲治疗仪（低周波治疗器）
型号：TENS21
生产企业：株式会社好玛研究所（日本）
分类：二类有源医疗器械
组成：主机、温热电极、电极导线、固定绑带、遥控器
预期用途：经皮肤电刺激神经、肌肉，实现镇痛，预防及缓解肌肉废用性萎缩。
供电方式：交流市电；具备定时停机、强度调节、恒温加热多重安全机制。
适用科室：康复医学科、疼痛科、骨科、神经内科、理疗科。
使用限制：医疗机构内专业人员操作；严格遵守禁忌症与摆放规范。
English
Product Name: Low Frequency Electronic Pulse Therapy Device (Low Frequency Therapy Unit)
Model: TENS21
Manufacturer: HOMER ION Research Institute (Japan)
Classification: Class II active medical device
Components: Main unit, thermoelectrodes, electrode cables, fixing straps, remote controller
Intended Use: Transcutaneous electrical stimulation of nerves and muscles for analgesia, prevention and relief of disuse muscular atrophy.
Power Supply: AC mains power; equipped with multi-safety mechanisms: automatic timer shutdown, intensity adjustment, constant temperature heating.
Applicable Departments: Rehabilitation Medicine, Pain Department, Orthopedics, Neurology, Physical Therapy Department.
Restriction: Operated only by professional staff in medical institutions; strictly comply with contraindications and electrode placement rules.
以上产品详情仅供参考，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.
Shanghai Kangshida Medical Devices Co., Ltd.
does not manufacture medical products. All products are sourced from respective manufacturers,
agents and distributors.
Please contact us in case of any infringement, and we will handle it promptly.
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