Fetal Doppler for Portable Use with Ce and ISO
用于便携式使用的Ce和ISO的胎儿多普勒
| 型号。 | 麦粒肿，fd05 |
| 类型 | 数字成像系统 |
| 组 | 女 |
| 医疗器械注册/记录号 | 6018982323 |
| 超声波输出功率 | P < 10 MW10 MW |
| 商标 | 舜天 |
| 起源 | 中国江苏 |
| 分类 | 成像诊断设备 |
| 证明 | ce，iso13485 |
| 医疗器械监管类型 | 类型1 |
| 医疗器械广告批准号 | 6078340032 |
| 能量消耗 | < 0.8 W |
| 规范 | ISO和CE认证ified |
| HS编码 | 9018193000 |
袖珍胎儿多普勒是一种手持式产科单位，可用于医院，诊所和家庭孕妇进行日常自检，包含超声波信号发射器和接收器，模拟信号处理单元等的组件。它具有音频输出，并可与耳机或录音机连接音频输入。
主要特点
适合使用范围：适合在怀孕第十二周后使用
电池LED指示灯
低电量检查电池
内置扬声器
耳机输出
探头可以更换
探头检查
标准：2M直探头
选项：3M直探头，2M防水探头，3M防水探头，4/5 / 8M血管直探头
两片标准1.5V碱性电池，可工作不少于10小时。
主要表现
防电击类型：内部动力设备
抗电击度：B型应用零件
电压：DC 3 V
有害液体防护等级：普通设备（无液体密封设备）。
能量消耗： < 0.8 W.8 W
电源：两节1.5V（AA尺寸）碱性电池
FHR测量范围：50〜210BPM（BPM：每分钟跳动）
探测：
标称频率：2.0 MHz
工作频率：2.0MHz±10％smn; 10％smn; 10%
超声波输出功率：P < 10 mW0 mW
超声输出强度：Isata < 10 mW/cm2/cm2
负峰值声压：p_ < 0.5 MPa MPa
工作模式：连续波多普勒
传感器有效辐射面积：208 mm2±15％smn; 15％smn; 15%
物理特性
尺寸：（L）135mm×（W）95mm×（H）35mmes; （H）35mms; (H ) 35 mm
重量：约180克（含电池）
合格
通过了FDA和CE
易于处理和携带
可靠和一致。
包装：中性纸箱包装/ OEM可用
交货时间：2周内/取决于数量
主要特点
适合使用范围：适合在怀孕第十二周后使用
电池LED指示灯
低电量检查电池
内置扬声器
耳机输出
探头可以更换
探头检查
标准：2M直探头
选项：3M直探头，2M防水探头，3M防水探头，4/5 / 8M血管直探头
两片标准1.5V碱性电池，可工作不少于10小时。
主要表现
防电击类型：内部动力设备
抗电击度：B型应用零件
电压：DC 3 V
有害液体防护等级：普通设备（无液体密封设备）。
能量消耗： < 0.8 W.8 W
电源：两节1.5V（AA尺寸）碱性电池
FHR测量范围：50〜210BPM（BPM：每分钟跳动）
探测：
标称频率：2.0 MHz
工作频率：2.0MHz±10％smn; 10％smn; 10%
超声波输出功率：P < 10 mW0 mW
超声输出强度：Isata < 10 mW/cm2/cm2
负峰值声压：p_ < 0.5 MPa MPa
工作模式：连续波多普勒
传感器有效辐射面积：208 mm2±15％smn; 15％smn; 15%
物理特性
尺寸：（L）135mm×（W）95mm×（H）35mmes; （H）35mms; (H ) 35 mm
重量：约180克（含电池）
合格
通过了FDA和CE
易于处理和携带
可靠和一致。
包装：中性纸箱包装/ OEM可用
交货时间：2周内/取决于数量
| Model NO. | STY-FD05 |
| Type | Digital Imaging System |
| Group | Female |
| Medical Devices Reg./Record No. | 6018982323 |
| Ultrasound Output Power | P < 10 MW10 MW |
| Trademark | SAINTY |
| Origin | Jiangsu, China |
| Classification | Imaging Diagnostic Equipment |
| Certification | CE, ISO13485 |
| Medical Device Regulatory Type | Type 1 |
| Medical Devices Ad. Approval No. | 6078340032 |
| Power Consumption | < 0.8 W |
| Specification | ISO & CE Certifiedtifiedified |
| HS Code | 9018193000 |
A Pocket Fetal Doppler is a hand-held obstetrical unit, which can be used in hospital, clinic and home for daily self-check by pregnant woman.It contains components of ultrasonic signal transmitter and receiver, analog signals processing unit etc. It has audio output and can be connected with earphone or recorder with audio input.
Main Features
Suitable Using Range: Suitable for use after the 12th week of pregnancy
Battery LED indicator
Low power inspection of the battery
Built-in speaker
Output for headphones
The probe can be changeable
Probe inspection
Standard:2M straight probe
Option:3M straight probe,2M water proof probe,3M water proof probe,4/5/8M vascular straight probe
Two pieces of standard 1.5V alkaline battery available which can work no less than 10 hours.
Main performance
Anti-electroshock Type: Internally powered equipment
Anti-electroshock Degree: Type B applied part
Voltage: DC 3 V
Harmful Liquid Proof Degree:Ordinary equipment (sealed equipment without liquid proof).
Power Consumption: < 0.8 W.8 W
Power Supply: TWO 1.5V(AA size)alkaline battery
FHR Measuring Range: 50~210BPM (BPM: beat per minute)
Probe:
Nominal Frequency: 2.0 MHz
Working Frequency: 2.0MHz ± 10%smn; 10%smn; 10%
Ultrasound Output Power: P < 10 mW0 mW
Ultrasonic Output Intensity: Isata < 10 mW/cm2/cm2
Negative Peak Sound Pressure: p_ < 0.5 MPa MPa
Working Mode: Continuous wave doppler
Effective Radiating Area of Transducer: 208 mm2 ± 15%smn; 15%smn; 15%
Physical Characteristic
Dimension: (L) 135 mm × (W) 95 mm × (H ) 35 mmes; (H ) 35 mms; (H ) 35 mm
Weight: About 180 g (including batteries)
Qualification
Passed FDA and CE
Easy to handle and carry
Reliable and consistent.
Packing: neutral carton packing / OEM available
Lead time: within 2 weeks / depending on quantity
Main Features
Suitable Using Range: Suitable for use after the 12th week of pregnancy
Battery LED indicator
Low power inspection of the battery
Built-in speaker
Output for headphones
The probe can be changeable
Probe inspection
Standard:2M straight probe
Option:3M straight probe,2M water proof probe,3M water proof probe,4/5/8M vascular straight probe
Two pieces of standard 1.5V alkaline battery available which can work no less than 10 hours.
Main performance
Anti-electroshock Type: Internally powered equipment
Anti-electroshock Degree: Type B applied part
Voltage: DC 3 V
Harmful Liquid Proof Degree:Ordinary equipment (sealed equipment without liquid proof).
Power Consumption: < 0.8 W.8 W
Power Supply: TWO 1.5V(AA size)alkaline battery
FHR Measuring Range: 50~210BPM (BPM: beat per minute)
Probe:
Nominal Frequency: 2.0 MHz
Working Frequency: 2.0MHz ± 10%smn; 10%smn; 10%
Ultrasound Output Power: P < 10 mW0 mW
Ultrasonic Output Intensity: Isata < 10 mW/cm2/cm2
Negative Peak Sound Pressure: p_ < 0.5 MPa MPa
Working Mode: Continuous wave doppler
Effective Radiating Area of Transducer: 208 mm2 ± 15%smn; 15%smn; 15%
Physical Characteristic
Dimension: (L) 135 mm × (W) 95 mm × (H ) 35 mmes; (H ) 35 mms; (H ) 35 mm
Weight: About 180 g (including batteries)
Qualification
Passed FDA and CE
Easy to handle and carry
Reliable and consistent.
Packing: neutral carton packing / OEM available
Lead time: within 2 weeks / depending on quantity
