2 Definitions
ers2 – 1-Channel ECG Telemetry System
15
201000401000 / Rev 04
2.3.2
System and Data Security
Medical device security is a shared responsibility between all stakeholders. These are healthcare
facilities, patients, employees, and manufacturers of medical devices. Failure to maintain cyber-
security can result in compromised device functionality, loss of data (medical or personal) avail-
ability or integrity, or expose other connected devices or networks to security threats.
2.3.3
EMS/EMC/RF Warning
The ECG system is designed to comply with applicable regulations regarding EMC (electromagnetic
compatibility). Its compliance with these requirements has been verified. Changes or modifications
to this system not expressly approved by ergoline could cause EMC issues with this or other equip-
ment. RF devices may adversely affect the usability or accuracy of the device or system. During
installation and use of the device or system, known RF sources in the vicinity need to be taken into
account. These sources include:
• Radio and TV stations
• Portable and mobile radio communication equipment (cell phones, radios)
• X-ray, CT, or MRI equipment
These devices are possible sources of interference as they may emit higher levels of electromagnetic
radiation.
NOTICE
Protection from unauthorized access
Lock the 1-channel transmitter in a cabinet when not in use.
NOTICE
Protection from unauthorized access
Switch off the 1-channel transmitter if not used for long periods of time.
NOTICE
Protection from unauthorized access
Inform your ergoline service partner if a 1-channel transmitter is stolen or lost.
WARNING
Malfunction of the ECG system
Use of portable telephones or other RF devices near the ECG system may cause unexpected or
adverse operation.
Do not use portable telephones or other RF devices near the ECG system.
WARNING
Accessories or components
Adding accessories or components to the ECG system or modifying the device or system may result
in increased emissions or decreased electromagnetic immunity of the device or system.
More information on EMS/EMC and RF can be obtained from these sources:
Appendix "Electromagnetic Compatibility" in this system manual.
NOTICE
This device complies with part 15 of the FCC rules
Operation is subject to the following two conditions:
(1) This device may not cause harmful interference, and
(2) this device must accept any interference received, including interference that may cause unde-
sired operation.
NOTICE
Changes or modifications made to this device not expressly authorized by ergoline GmbH may void
the FCC authorization to operate this device.
NOTICE
Information about exposure to radiofrequency emitted by radiation
The radiated output power of the device is far below the FCC limits for RF emissions. However, any
potential human contact during normal operation of the device should be considered and reduced
to a minimum.
