CBET Ultimate 5

Question 1

What is the primary difference between a Class I and Class II medical device under FDA classification?

Accepted Answer

Class I requires general controls only; Class II requires special controls such as performance standards

Answer

Class I devices are implantable; Class II are external only

Answer

Class I is for diagnostic devices; Class II is for therapeutic devices

Answer

Class I requires PMA; Class II requires 510(k) clearance only

Question 2

A physiological pressure transducer requires zeroing before use. Why is this step necessary?

Accepted Answer

To establish atmospheric pressure as the reference baseline, eliminating hydrostatic and offset errors

Answer

To calibrate the gain of the amplifier

Answer

To test the transducer's frequency response

Answer

To prime the fluid-filled tubing

Question 3

Which parameter does a capnograph measure, and what waveform phase indicates end-tidal CO2?

Accepted Answer

CO2 concentration in exhaled breath; the alveolar plateau (Phase III)

Answer

SpO2; the dicrotic notch

Answer

Airway pressure; peak inspiratory pressure

Answer

Respiratory rate; the expiratory downslope

Question 4

During a PM on a hospital bed, you discover the brake does not engage fully. What is the correct action?

Accepted Answer

Tag the bed out-of-service and remove from patient use pending repair

Answer

Notify nursing and continue using the bed with caution

Answer

Apply lubricant to the brake mechanism and recheck

Answer

Document the finding and schedule repair for next month

Question 5

What is the purpose of a Faraday cage in an MRI suite?

Accepted Answer

To shield external RF signals that would corrupt MRI image quality

Answer

To cool the superconducting magnet

Answer

To contain cryogenic helium gas

Answer

To protect staff from gradient field exposure

Question 6

A hospital is evaluating a new ultrasound machine. Under FDA guidance, which testing verifies the acoustic output does not exceed safe limits?

Accepted Answer

AIUM/NEMA measurement standards for acoustic output (MI and TI indices)

Answer

IEC 60601-1 electrical safety testing

Answer

NFPA 99 medical gas testing

Answer

ANSI Z136 laser safety standards

Question 7

A nurse reports that an automated external defibrillator (AED) failed to advise a shock during a cardiac arrest drill. After replacing the dummy pad, it still shows 'check electrodes.' What should the BMET do next?

Accepted Answer

Test the AED's electrode impedance sensing circuit using a calibrated AED analyzer

Answer

Replace the battery immediately

Answer

Return the AED to service; drills are not representative

Answer

Update the AED firmware