The usability failure mode

Recommended protection

Validation

The user does not notice the sound alarm

If the alarm signal is similar to sound generated by other equipment, then the users might fail to notice it.

Alarm perception assurance

The system should always provide a special visual alarm, visible all around the patient, indicating that the alarm is muted.

Usability testing

Use the Training mode for the testing

Make sure that the sound alarms do not resemble any equipment used in the patients' surrounding, such as microwave oven.

The user does not notice the visual alarm

IEC 60601-1-8 (for example, section 6.3.2) permits the use of either visual or sound alarms.

Visual backup

Salient visual signals should always accompany the sound alarm signals.

Usability testing

Use the Training mode for the testing