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Since the standardization and upward trend of audible alarms in medical devices in 2003, these machines have saved many lives within intensive care units and emergency rooms. The addition of these alarms has notified nurses and doctors of the condition of the patient when they are out of the room. There are several characteristics of audible alarms within therapeutic devices set forth by international standard IEC 60601-1-8.
The IEC 60601-1-8 Requirement
The IEC 60601-1-8 specification requires medical devices to have an individual sound pulse with a frequency between 150 and 1,000 Hz. Also, there must at least four harmonic tones between 300 and 4,000 Hz. To the human ear, the sounds of all five requirements blended together would sound like four diverse musical notes playing simultaneously. An additional requirement is the sound level of the harmonic tones need to be within +15dB and -15dB of the main frequency.
Other Alarms
In addition to the above requirement, the specification allows medical device manufacturers to provide more than warning alarm sounds. This means medical devices would simply play a musical melody as opposed to constantly beeping. Different musical sequences are used for different medical issues. By utilizing dissimilar alarms for different conditions, it is hoped the medical staff will familiarize themselves with the sounds and be instantly prepared based on the melody.
Alarm Level Requirements
The IEC 60601-1-8 standard simply has basic requirements as to the loudness of the alarm with the only requisite being the highest priority condition being the loudest. A common recommendation is to have 3 to 6 dB levels between each priority alarm. The human ear can only recognize a pitch difference of 3dB levels and above. In general, there must be a small range between the highest and lowest priority alarm melodies so as to not distract others but be able to be informed of low conditions.
