User's Manual

27
All safeguards for the devices will be provided throughout the stated warranty period or until a
replacement product is available. In the rare event of a cybersecurity attack on the programmer
that affects its ability to program the pulse generator, implanted device therapy will continue.
St. Jude Medical encourages the clinics to allow only authorized healthcare providers to use the
Merlin™ PCS, for example by requiring badged access to programmer locations. The
cybersecurity bill of materials (CBOM) is available upon request.
Bluetooth Communication
For Bluetooth
®
Low Energy wireless communication, the Merlin PCS and St. Jude Medical
implantable devices should be within 2.5 meters in normal use.
The programmer uses BLE with authentication methods to ensure that the programmer
communicates only with St. Jude Medical authorized products. The integrity and confidentiality of
all data-in-transit during BLE communication is protected by multiple levels of encryption.
Inductive Communication
Inductive Communication is a short-range communication channel that protects patient
information by the proximity of the telemetry wand to the device.
Only authorized healthcare providers should place the inductive wand over the device.
RF Communication
To begin Merlin™ PCS use, the clinician places the programmer's inductive telemetry wand over
the patient's implanted device and initiates communication. The inductive wand has a range of
less than 7 centimeters in normal use. The Merlin PCS then switches to Medical Implant
Communications Service (MICS)-based (RF) telemetry if the implanted device supports it. The RF
telemetry range is less than 2.5 meters in normal use.
St. Jude Medical implantable devices introduced in 2010 and later use proprietary
communications protocol based on magnetic induction and, for certain models, an MICS-based
protocol. This protocol prevents unauthorized device communication and recording and protects
sensitive patient information using:
 An authentication algorithm
 Data encryption
NOTE: The implanted device authenticates telemetry communication before accepting
changes to programmed therapy.
Electromagnetic Compatibility
The Merlin™ PCS and the Merlin™ Antenna require special precautions with regard to
electromagnetic compatibility (EMC) and should be used in accordance with the information
provided in this manual.
The Merlin PCS and the Merlin Antenna comply with the requirements of the EMC international
standard IEC 60601-1-2 when used with the cables listed in Accessories (page 34).
The Merlin PCS and the Merlin Antenna are intended for use in the electromagnetic environment
specified in the following tables. The user should ensure that it is used in such an environment.
WARNING: The Merlin PCS and the Merlin Antenna are intended for use only by
healthcare professionals. They comply with the limits for medical devices contained in
IEC/EN 60601-1-2.
However, the Merlin PCS and the Merlin Antenna may cause radio interference or may