When using the HeartStart XL+, electromagnetic compatibility with surrounding devices should be
A medical device can either generate or receive electromagnetic disturbances. Testing for electromagnetic
compatibility EMC with the appropriate accessories has been performed according to the international
standard for EMC for medical devices (IEC 60601-1-2). This IEC standard has been adopted in Europe
as the European Norm (EN 60601-1-2).
The EMC standards describe tests for both emitted and received interference. Emission tests deal with
electromagnetic disturbances generated by the device being tested.
WARNINGS: Radio frequency (RF) disturbances or emissions from devices other than the HeartStart XL+ might
degrade performance of the HeartStart XL+. Electromagnetic compatibility with surrounding devices
should be assessed prior to using the defibrillator.
Fixed, portable, and mobile radio frequency communications equipment could affect the performance of
medical equipment. See
between RF communications equipment and the HeartStart XL+.
Reducing Electromagnetic Interference
The HeartStart XL+ and associated accessories might be susceptible to interference from other RF energy
sources and continuous, repetitive, power line bursts. Examples of other equipment that can cause RF
interference are medical devices, cellular products, information technology equipment and
radio/television transmission. Should interference be encountered, as demonstrated by artifact on the
ECG or dramatic variations in parameter measurement values, attempt to locate the source. Assess:
Is the interference intermittent or constant?
Does the interference occur only in certain locations?
Does the interference occur only when in close proximity to certain medical devices?
Do parameter measurement values change dramatically when the AC line cord is unplugged?
Once the source is located, attempt to attenuate the EMC coupling path by distancing the
monitor/defibrillator from the source as much as possible. If assistance is needed, call your local service
Essential Performance Determinations
per 60601-1-2: Ed. 2
Essential performance of the HeartStart XL+ defibrillator/monitor derived from the product's risk
The ability to deliver defibrillation therapy (manual, AED and Synchronized Cardioversion).
The ability to deliver pacing therapy (fixed and demand).
This includes ancillary functions, such as ECG, which affect the ability to deliver defibrillation or pacing
All other functions are considered nonessential performance but were monitored for EMC.
on page 213 for the minimum recommended separation distance