厂商供应国际听力儿童听力计PA5
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厂商供应国际听力儿童听力计PA5
桂经理19117326863微xin同号
管理类别
第二类
型号规格
PA5
结构及组成/主要组成成分
由主机（电源处理、信号处理、放大和控制器）及电声换能器（扬声器）合为一体构成。
适用范围/预期用途
该产品为用于检查儿童听力损失的设备。
一、工作原理（Working Principle）
中文
声场测听原理通过内置扬声器发射 500–4000Hz 啭音（Warble Tone）、窄带噪声（NB）、白噪声（WN），按 10dB 步进 控制声强（30–80dB HL），利用儿童听觉定向反射（COR）、视觉强化（VRA）、耳睑反射（APR） 判断听阈，无需耳机、适合低龄不配合儿童。
声光联合刺激原理同步触发 三角形 3 颗红色 LED 闪烁（5Hz） 与声刺激，形成声 - 光条件反射，提升儿童注意力与反应率，降低测试伪影，提高筛查准确性。
自动校准原理接入 TDH39 耳机时自动切换为纯音测听模式，按 ISO 389-1 标准校准；声场模式按 ISO 389⁻⁷ 校准，50cm/16cm 双距离自动补偿声强（16cm 时自动 +10dB）。
English
Soundfield Audiometry PrincipleBuilt-in speaker delivers 500–4000Hz warble tones, NB/WN; 10dB steps (30–80dB HL); uses COR/VRA/APR pediatric behavioral reflexes to estimate thresholds; headphone-free for young/uncooperative children.
Audio-Visual Stimulation PrincipleTriangular 3 red LEDs (5Hz flash) synchronize with sound; ｆorms sound-light conditioning to boost attention/response rate, reduce artifacts, improve screening accuracy.
Auto-Calibration PrincipleAuto-switches to pure-tone mode with TDH39 (ISO 389-1); soundfield calibrated (ISO 389⁻⁷); 50cm/16cm auto-compensation (+10dB at 16cm).
二、产品功能（Product Functions）
中文
1. 儿童声场筛查
频率：500/1000/2000/3000/4000Hz（5 个关键言语频率）
刺激：啭音（5Hz 调制）、窄带噪声、白噪声
强度：30–80dB HL（50cm）、20–70dB HL（NB）、16cm 自动 +10dB
模式：单手按键、无声操作、声光同步 / 单独触发
2. 条件化测试
COR（条件定向反射）：0–12 个月婴儿，声源定位反应
VRA（视觉强化测听）：1–4 岁，声光联合强化
APR（耳睑反射）：0–4 个月新生儿，声音诱发眨眼 / 惊跳
3. 成人纯音测听（选配）
接 TDH39 耳机：自动校准、纯音测听、30–80dB HL
4. 智能省电
闲置自动关机、按键唤醒、电池寿命长
English
1. Pediatric Soundfield Screening
Frequencies: 500/1000/2000/3000/4000Hz (5 key speech frequencies)
Stimuli: Warble (5Hz), NB, WN
Levels: 30–80dB HL (50cm), 20–70dB HL (NB), +10dB at 16cm
Operation: One-hand, silent switches, sound/light sync/separate
2. Behavioral Testing
COR: 0–12m, localization reflex
VRA: 1–4y, audio-visual reinforcement
APR: 0–4m, blink/startle reflex
3. Adult Pure-Tone (Optional)
TDH39: auto-calibrated, pure-tone, 30–80dB HL
4. Smart Power
Auto shut-off, wake-on-key, long battery life
三、产品特点（Product Features）
中文
儿童专属：声光联合刺激、低龄适配、无声按键、防干扰
超轻便携：仅 360g（含电池）、25×7×5cm、单手可握
双模式：声场筛查（儿童）+ 耳机纯音（成人）一机两用
操作极简：3 按键（选择 / 刺激 / 灯光）、10dB 步进、无需培训
稳定可靠：CE 0123、IEC 60645-1 Type 5、医用安全
电池：3 节 AA 电池、待机 12 个月、连续测试 10 小时
双距离校准：50cm（标准）/16cm（近距离）自动补偿
无声设计：按键无噪音、避免干扰测试环境
English
Pediatric-Optimized: Audio-visual, silent keys, infant-friendly
Ultra-Portable: 360g (w/batt), 25×7×5cm, one-hand operation
Dual-Mode: Soundfield (ped) + TDH39 (adult) in one
Simple UI: 3 buttons (select/stim/light), 10dB steps
Compliant: CE 0123, IEC 60645-1 Type 5, medical safe
Long Battery: 3×AA, 12m standby, 10h continuous
Dual-Distance: 50cm/16cm auto-level compensation
Silent Operation: No switch noise, test-environment friendly
四、技术参数（Technical Specifications）
中文
频率范围：500、1000、2000、3000、4000Hz
刺激类型：啭音（5Hz ±5%）、窄带噪声（NB）、白噪声（WN）
强度范围
声场（50cm）：啭音 / 白噪声 30–80dB HL（10dB 步进）
窄带噪声：20–70dB HL（10dB 步进）
16cm 距离：所有强度自动 +10dB
光刺激：3 颗红色 LED、三角形排列、5Hz 闪烁
换能器：内置扬声器、选配 TDH39 耳机
电源：3×AA（LR6）碱性 / 充电电池、自动省电
尺寸 / 重量：250×70×50mm、360g（含电池）
标准：IEC 60645-1 Type 5、ISO 389-1/⁻⁷、CE 0123
环境：工作 10–35℃、湿度 15–90%（无冷凝）
English
Frequencies: 500, 1000, 2000, 3000, 4000Hz
Stimuli: Warble (5Hz ±5%), NB, WN
Level Ranges
50cm: Warble/WN 30–80dB HL (10dB steps)
NB: 20–70dB HL (10dB steps)
16cm: All levels +10dB auto
Light: 3 red LEDs, triangle, 5Hz flash
Transducers: Built-in speaker, optional TDH39
Power: 3×AA (LR6) alkaline/NiMH, auto-power save
Dimensions/Weight: 250×70×50mm, 360g (w/batt)
Standards: IEC 60645-1 Type 5, ISO 389-1/⁻⁷, CE 0123
Environment: 10–35℃, 15–90%RH (non-condensing)
五、使用方法（Usage Method）
中文
准备
装 3 节 AA 电池、开机自检、确认电量
环境：安静室（噪声 <40dB (A)）、儿童坐位、家长陪同
模式：声场（儿童）/ 耳机（成人）选择
儿童声场测试（COR/VRA）
选频率（500/1000/2000/3000/4000Hz）
选强度（30dB 起步）、按「刺激」键（声光同步）
观察反应（转头 / 眨眼 / 惊跳）→ 有反应降 10dB，无反应升 10dB
记录阈值、换耳 / 换频率重复
成人纯音测试
接 TDH39 耳机、自动校准、纯音测听、记录阈值
结束
关机、清洁机身、电池长期不用取出
English
Preparation
Insert 3×AA, power on, self-test, check battery
Environment: quiet room (<40dB(A)), child seated, parent present
Mode: soundfield (ped) / TDH39 (adult)
Pediatric Soundfield (COR/VRA)
Select frequency → set level (start 30dB) → press Stim (sound+light)
Observe response (turn/blink/startle): ↓10dB if yes, ↑10dB if no
Record threshold; repeat for other ear/freq
Adult Pure-Tone
Connect TDH39 → auto-calibrate → pure-tone test → record
Completion
Power off; clean; remove batteries if stored long
六、适应症（Indications）
中文
新生儿 / 婴儿：0–12 个月 APR/COR 听力筛查
幼儿 / 学龄前：1–6 岁 VRA 听力筛查、言语频率评估
不配合儿童：智力障碍、自闭症、哭闹无法配合者
社区 / 家庭筛查：妇幼保健、幼儿园、家庭快速听力检测
成人简易测听：选配耳机、门诊初步纯音筛查
随访监测：中耳炎、感音神经性听力损失定期复查
English
Newborn/Infant: 0–12m APR/COR screening
Toddler/Preschool: 1–6y VRA screening, speech-freq assessment
Uncooperative Children: intellectual disability, autism, unmanageable
Community/Home: maternal/child care, kindergarten, rapid screening
Adult Screening: optional TDH39, basic pure-tone check
Monitoring: otitis media, SNHL follow-up
七、禁忌症（Contraindications）
中文
绝对禁忌
急性外耳道炎 / 湿疹、严重耳痛、活动性流脓
外耳道闭锁 / 严重狭窄、鼓膜穿孔急性期
癫痫发作期、严重惊厥、无法安静刺激
皮肤感染 / 破损（声光刺激无接触，相对宽松）
相对禁忌
极度烦躁 / 哭闹无法安抚（需镇静 / 睡眠后测试）
严重感冒 / 鼻塞（影响中耳功能，结果偏差）
环境噪声 >50dB (A)（无法准确筛查）
English
Absolute Contraindications
Acute otitis externa/eczema, pain, active otorrhea
Canal atresia/stenosis, acute TM perforation
Active epilepsy, severe convulsions, untestable
Skin infection (non-contact, less restrictive)
Relative Contraindications
Uncontrollable crying (sedate/sleep before test)
Severe cold/congestion (middle ear artifact)
Ambient noise >50dB(A) (invalid results)
八、注意事项（Precautions）
中文
操作：环境安静 <40dB (A)；远离手机 / 电磁干扰；单手稳定握持
儿童：测试前安抚、避免饥饿 / 困倦；声光同步提升反应率
距离：严格 50cm/16cm；近距离自动 +10dB 勿手动修改
电池：用碱性电池；长期存储取出电池；低电及时更换
清洁：75% 酒精擦外壳；禁液体渗入扬声器 / 按键
质控：每月自检；异常联系厂家校准；排除伪反应
解读：筛查阳性需 ABR/OAE 确诊；仅为筛查非诊断
English
Operation: Quiet <40dB(A); avoid EMI; steady one-hand hold
Pediatric: Calm before test; avoid hunger/sleep; sync sound+light
Distance: Strict 50cm/16cm; no manual override +10dB at 16cm
Battery: Use alkaline; remove for storage; replace low battery
Cleaning: 75% alcohol wipe; no liquid into speaker/keys
QC: Monthly self-test; calibrate if faulty; reject false responses
Interpretation: Screen positive needs ABR/OAE confirm; screening only
九、存储条件（Storage Conditions）
中文
温度：工作 10–35℃；存储 -20–+60℃
湿度：15%–90%（无冷凝）
气压：98–104kPa
环境：干燥、通风、无尘；远离热源、腐蚀、强电磁
设备：装入便携袋；电池取出；避免挤压 / 跌落；定期自检
English
Temperature: Operating 10–35℃; Storage -20–+60℃
Humidity: 15%–90%RH (non-condensing)
Pressure: 98–104kPa
Environment: Dry, ventilated, dust-free; away from heat/corrosion/EMI
Equipment: Store in pouch; remove batteries; avoid shock/drop; self-test regularly
十、说明书核心信息（Manual Core）
中文
制造商：Interacoustics A/S（丹麦）；CE 0123；IEC 60645-1 Type 5
型号：PA5 手持式儿童听力计
标准：EN 60645-1、ISO 389-1/⁻⁷、EN 60601-1-2
维护：每月自检；年度校准；电池每 1–2 年更换
故障：无声音 → 查电池 / 扬声器；灯光不亮 → 换电池 / LED；校准失败 → 返厂
保修：整机 2 年；配件 1 年；人为损坏 / 非授权维修除外
安全：医用二类、儿童安全、禁易燃环境、专业人员
English
Manufacturer: Interacoustics A/S (Denmark); CE 0123; IEC 60645-1 Type 5
Model: PA5 Handheld Pediatric Audiometer
Standards: EN 60645-1, ISO 389-1/⁻⁷, EN 60601-1-2
Maintenance: Monthly self-test; annual calibration; replace batteries 1–2y
Troubleshooting: No sound → check batt/speaker; no light → batt/LED; calibration fail → service
Warranty: 2-year system; 1-year accessories; exclude damage/unauthorized repair
Safety: Class II, child-safe, no flammable areas, professional use only
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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