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Dysphagia Treatment

Dysphagia Treatment
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Dysphagia Treatment

Product catalog summary

Medical Device Single Audit Program (MDSAP) Overview

The document references the Medical Device Single Audit Program (MDSAP), which is a regulatory framework designed to allow a single regulatory audit of a medical device manufacturer that satisfies the requirements of multiple regulatory jurisdictions.

Technical Parameters of Ultrasound Device

  • Device Type: Wearable Ultrasound
  • Frequency: 3 MHz
  • Intensity: 0.6 W/cm²
  • Work Duration: 26 minutes and 40 seconds
  • Time Reference: 14:50 (likely start or measurement time)
  • Signal Characteristics: 200 Hz pulse repetition frequency, pulse duration in microseconds (μs) implied

Interpretation and Context

The document appears to combine regulatory program information (MDSAP) with technical specifications of a wearable ultrasound device, possibly for medical therapeutic or diagnostic use. The parameters such as frequency, intensity, and duration are critical for ensuring device safety and efficacy, which are key considerations under MDSAP audits.

Key Points and Recommendations

  • Ensure compliance with MDSAP audit requirements for documentation and device performance.
  • Maintain accurate records of ultrasound device parameters including frequency, intensity, and operational time.
  • Adhere to safety limits for ultrasound intensity to prevent tissue damage.
  • Use the specified parameters consistently during device operation to meet regulatory and clinical standards.
See more

Catalog excerpts

Dysphagia Treatment-1

healthcare &Medical Ultrasonic Dysphagia Treatment ► KM300 Wearable Therapeutic Ultrasound ► KM250 Dysphagia Treatment Device Function: Neuromuscular reeducation; NMES treatment; Mimics swallowing; For dysphagia patients. Feature: 2 channels; 3 treatment modes; Parameter customization; TFT display; Hight-adjustable; Voice prompts. Power: DC 3.7V 900mAh Li-ion battery Contents: Device; Electrode wire; USB cable; User manual; Swallowing electrode pads. Function: Targeted therapeutic ultrasound; Pain relief ultrasound therapy; Wearable ultrasound system. Feature: No gel; Ultrasonic frequency 3MHz; 0.4W; Power: DC 3.7V 900mAh Li-ion battery Contents: Device; Electrode wire; USB cable; Ultrasonic pads; User manual. ► KM250Pro Biofeedback Dysphagia Treatment Device Function: Reeducation and Biofeedback; EMG/ ETS/ STIM; Mimic swallowing for dysphagia patients. Feature: 2 channels and trigger swallowing; Preset and customizable programs; TFT color display; Highly-adjustable; Voice prompts. Power: DC7.4V 1200mAh Li-ion battery Contents: Device; Electrode wires; REF signal wire; USB cable; Swallowing electrode pads; Electrode pads; User manual. ► KM300Pro Wearable Therapeutic Ultrasound with TENS Function: Pain relief ultrasound and TENS therapy; Relief muscle spasms; Wearable ultrasound system; Feature: No gel; Ultrasonic frequency 3MHz; 0.4W; Power: DC 3.7V 900mAh Li-ion Battery Contents: Device; Electrode wire; USB cable; Electrode pads; Ultrasonic pads; User manual. ► KM302All-digital Ultrasound Therapy Device Function: Treat soft tissue injuries; Relieve muscle spasm; Relief muscular pain. Feature: 1MHz frequency; 0-30 min adjustable using time; 0-10 adjustable levels of gear; 15W. Power: Power input DC4V±0.5V/ 2.5A Contents: Device; Adapter.

 Open the catalog to page 1

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