Medical Devices Flashcards
1
Q
What is a medical device?
A
Any instrument for the purpose of diagnosis, prevention, monitoring, treatment or
alleviation of disease.
2
Q
Give some examples of medical devices?
A
Equipment = stethoscope, defibrillator, spirometer
Consumables = venous cannula, ECG electrode, BP cuff
3
Q
What is the frequency range for ECG?
A
0.05 to 100 Hz
4
Q
What is the sampling rate for ECG?
A
2000 to 8000 samples per second
5
Q
What is the medical equipment lifecycle?
A
Clinical need
specification
purchase
testing
use
repair or maintenance
decommissioning
disposal
6
Q
What are the two electrical classes?
A
- Class 1 (protectively earth)
- Class 2 (double insulated)
7
Q
Define medical device adverse incident and what do you do?
A
- Any event involving a medical device that has harmed a patient/staff or where the potential to do so is significant
- Ensure patient safety, do not change device settings. Do not remove consumables or their packaging, complete DATIX, quarantine the device, securely affix a note.
