| 1 | Clinical application | Confirm that the transducer is intended for the required examination, such as abdominal, vascular, cardiac, obstetric, or superficial imaging. | Intended-use statement, product specifications, and applicable regulatory labeling. | Match the transducer's declared applications with the department's examination protocols. |
| 2 | Frequency range | Use lower frequencies for deeper penetration and higher frequencies for superficial structures. A typical diagnostic range may be approximately 2–15 MHz, depending on transducer design. | Published operating-frequency range and examination-depth data. | Check whether the frequency range supports the target anatomy and required image depth. |
| 3 | Acoustic output safety | Review displayed MI ≤ 1.9 and TI ≤ 6.0 against the applicable FDA-cleared labeling and system configuration. MI represents mechanical effects; TI estimates potential tissue heating. | Acoustic-output table, system user manual, regulatory submission documents, and on-screen output display. | Verify the highest applicable MI and TI values across supported operating modes, presets, and output-power settings. |
| 4 | IEC safety compliance | Confirm evaluation against IEC 60601-2-37, which specifies particular requirements for the basic safety and essential performance of ultrasonic medical diagnostic and monitoring equipment. | Current test report or certificate covering IEC 60601-2-37, together with the applicable IEC 60601-1 safety documentation. | Check certificate scope, tested configuration, standard edition, and report validity. |
| 5 | Electrical protection | Confirm appropriate protection against electric shock, leakage current, and applied-part hazards for the intended clinical environment. | Electrical-safety test report, applied-part classification, and equipment protection rating. | Verify that the transducer and compatible ultrasound system are tested as the intended medical equipment configuration. |
| 6 | Surface temperature | Review probe-surface temperature limits and any special restrictions for endocavitary, neonatal, pediatric, or prolonged-contact examinations. | Thermal test results, operating instructions, and cleaning or warm-up requirements. | Confirm that maximum surface temperature and contact-time instructions are suitable for the intended patient population. |
| 7 | Ingress protection and durability | Check the stated protection against fluid ingress, impact, cable bending, connector stress, and repeated clinical handling. | Ingress-protection rating where applicable, environmental specifications, and durability test results. | Compare the rated protection with operating conditions such as bedside use, fluid exposure, and transport frequency. |
| 8 | Disinfection compatibility | Ensure that approved cleaning and disinfection methods are compatible with the transducer materials, cable, lens, and connector. | Validated reprocessing instructions listing compatible disinfectants, concentration, contact time, and temperature. | Confirm that the facility's infection-control procedure does not exceed the stated chemical or mechanical limits. |
| 9 | Image quality and performance | Assess axial resolution, lateral resolution, penetration, uniformity, dead zone, frame rate, and sensitivity using a suitable test object. | Acceptance-test results, phantom measurements, and representative clinical images. | Compare measurements with the procurement specification and establish a baseline for periodic quality control. |
| 10 | Compatibility and lifecycle support | Verify connector compatibility, supported imaging modes, software requirements, calibration support, warranty terms, and replacement availability. | Compatibility matrix, service documentation, calibration procedure, warranty conditions, and maintenance schedule. | Confirm that the complete transducer-system combination is authorized, serviceable, and supportable throughout the planned lifecycle. |