Background Overview

Global medical equipment is accelerating its intelligentization, and the requirements for the accuracy and reliability of pressure sensors in ventilators continue to increase. A Middle Eastern medical equipment manufacturer plans to upgrade its ventilator airway control system, which requires a differential pressure sensor module that can operate stably in a high temperature and dusty environment, and requires compatibility with European and American medical equipment certification standards. KKPCB proposes a customized PCBA solution based on its self-developed silicon piezoresistive pressure sensor, which is compatible with digital interfaces and complex working conditions.

 Application scenarios

● Core functions: Real-time monitoring of patient airway differential pressure signals, communication with the main control chip through the I2C/SPI interface, and dynamic adjustment of ventilator airflow output.

● Environmental adaptation: It needs to adapt to the extreme high temperatures (50℃+) in the desert areas of the Middle East and the low temperatures (-10℃) in winter in Europe to ensure the long-term stability of the sensor.

● Medical compliance: Meet EMC anti-interference standards and pass ISO 13485 medical device quality management system certification.

Product parameters

● Accuracy and resolution: ±0.25%FSS accuracy, 14-bit digital output, total error band ≤±0.5%.

● Interface and power supply: The barbed pressure interface has an anti-loosening design, supports 3.3V/5V dual voltage power supply, and I2C/SPI dual communication mode.

● Working condition adaptation: -20℃ to 85℃ wide temperature range compensation, differential pressure detection range covers 5kPa to 100kPa.

● Reliability: Built-in ASIC chip calibrates temperature drift, and SOIC16 package can be directly mounted on PCB.

Application results

KKPCB’s PCBA solution reduces the customer’s ventilator gas circuit control error to within ±0.4%, and the sensor has no signal attenuation under high-load operation at 55℃, and the equipment maintenance frequency is reduced by 30%. Passed ISO 13485 and EU CE certification, the whole machine failure rate is 25% lower than the industry average, and the customer’s product has achieved 5000 hours of trouble-free operation in actual tests in Middle East hospitals.

KKPCB’s core advantages in the case

●Medical-grade manufacturing capabilities:

Passed ISO 13485/IATF 16949 dual certification, 8 SMT production lines support ±0.03mm mounting accuracy, 100% X-RAY detection of solder joint defects.

Adopt high thermal conductivity FR4 substrate and gold-tin solder to cope with extreme temperature and humidity changes.

●Flexible service model:

Support small batch customization (minimum order of 100 pieces), 14-day delivery for European and American orders, and local component procurement in the Middle East to shorten the customs clearance cycle.

Provide one-stop service from PCB Layout optimization, component selection to functional testing to reduce customer development cycle.

●Global experience:

Cumulatively provide PCBA solutions for medical equipment manufacturers in 30+ countries, and 70% of products are exported to high-demand markets such as Europe, the United States, and the Middle East.

 Customized manufacturing solutions

For European and American customers:

●Solution design: double-layer PCB superimposed flexible board design , reduce signal loss, and be compatible with high-frequency SPI communication.

●Process optimization: optical alignment + nitrogen reflow process to avoid the risk of cold solder joints caused by high temperature oxidation.

●Localization support: Cooperate with European component agents to provide BOM support and achieve 7-day emergency replenishment through the international logistics center.

For Middle Eastern customers:

●Environmental protection: PCB surface sprayed with nano three-proof paint to prevent dust and salt spray erosion; MEMS sensor covered with metal shield .

●Mass production capacity: 10,000 pieces/day production capacity, supporting “PCB manufacturing + mounting + aging test” full process rapid response.

Actual application effect

Efficiency improvement: Customer product R&D cycle shortened by 40%, and the yield rate in the trial production stage increased from 78% to 95%.

Cost optimization: Through KKPCB ‘s centralized component procurement service, BOM cost was reduced by 12%.

Market competitiveness: Customer ventilator passed the Middle East GCC certification, market share increased by 15% within 1 year, and after-sales repair rate dropped to less than 1%.

 KKPCB — Global Partner for Medical Electronics Manufacturing

With high-reliability PCBA manufacturing capabilities as the core, we focus on the development of medical equipment sensor control modules, helping customers overcome extreme environmental challenges and accelerate global market layout!