BTC Clinical Procedures & Protocols 3 — Questions and Answers
Question 1: A surgical electrosurgical unit (ESU) is producing unintended burns at the patient return electrode site. What is the most likely protocol failure?
- Inadequate gel on the active electrode
- Poor contact or placement of the dispersive (return) electrode (Correct answer)
- Excessive output power setting
- Damaged hand-piece cable
Correct answer: Poor contact or placement of the dispersive (return) electrode
Inadequate contact of the dispersive electrode concentrates current at the return pad site, causing burns due to high current density.
Question 2: When leak current testing a Class I medical device, the maximum allowable patient lead leakage current under normal conditions is:
- 500 µA
- 100 µA
- 10 µA (Correct answer)
- 1000 µA
Correct answer: 10 µA
ANSI/AAMI ES60601-1 limits patient lead (applied part) leakage to 10 µA under normal conditions for Type CF equipment.
Question 3: Which action is required before connecting a newly received medical device to a patient for the first time in a hospital?
- Receive incoming inspection and safety testing (Correct answer)
- Obtain FDA 510(k) clearance documentation
- Perform a 30-day clinical trial
- Register the device with the state health department
Correct answer: Receive incoming inspection and safety testing
Incoming inspection and electrical safety testing are required before a device enters clinical service to ensure it meets safety standards.
Question 4: A nurse reports that a pulse oximeter probe causes skin irritation after prolonged use. The biomedical technician should:
- Adjust the alarm thresholds
- Inspect the probe for cracks and test current output compliance (Correct answer)
- Replace the monitor with a different brand
- Recommend the nursing staff use less adhesive
Correct answer: Inspect the probe for cracks and test current output compliance
Skin irritation can result from a cracked probe causing excessive light or current leakage; inspection and electrical testing identify the root cause.
Question 5: In the context of biomedical equipment maintenance, what does the acronym 'MSDS' (now called SDS) relate to?
- Medical Software Development Standards
- Material Safety Data Sheets for hazardous chemicals used in cleaning/disinfection (Correct answer)
- Maintenance Scheduling and Documentation System
- Medical Sensor Diagnostic System
Correct answer: Material Safety Data Sheets for hazardous chemicals used in cleaning/disinfection
SDS (formerly MSDS) provides information on hazardous chemicals including disinfectants and cleaning agents used in device maintenance.
Question 6: During a PM on an anesthesia machine, the technician performs a low-pressure leak test. A leak is detected. Which component is LEAST likely to be the cause?
- Vaporizer filler port
- Breathing circuit connections
- Flow control valve seats
- The high-pressure cylinder yoke (Correct answer)
Correct answer: The high-pressure cylinder yoke
The high-pressure yoke is upstream of the pressure regulators and is checked in the high-pressure leak test, not the low-pressure leak test.
Question 7: Which standard specifies alarm management requirements for medical devices used in healthcare facilities?
- IEC 62133
- ANSI/AAMI 2700-1 (Correct answer)
- UL 60950
- ISO 11135
Correct answer: ANSI/AAMI 2700-1
ANSI/AAMI 2700-1 (derived from IEC 60601-1-8) establishes alarm management requirements for medical devices in healthcare settings.
BTC Clinical Procedures & Protocols 3
A surgical electrosurgical unit (ESU) is producing unintended burns at the patient return electrode site.
What is the most likely protocol failure?