Medical Design Briefs - January 2023 - 36

Renamic Neo Offers Complete Wireless Connectivity to Implants
T
iotronik's Renamic Neo communicates with a medical
device implanted in a patient, such as a pacemaker,
ICD, or implantable cardiac monitor. The control unit received
FDA premarket approval in April 2022. The privately
owned medtech company has been developing medical
devices that improve the quality of life of patients suffering
from cardiovascular and endovascular diseases for more
than 50 years.
According to Biotronik, the Renamic Neo programmer
offers complete connectivity and a long battery runtime to
enable mobile use and workflow flexibility. Due to its compact
design, onboard PSA, SafeSync telemetry, and integrated
compartments, the device is designed to be convenient
to handle during clinical practice.
It offers complete wireless connectivity plus Ethernet and
USB, and it includes the company's ReportShare and EHR
export for paperless environment and remote consultation.
The device is significantly lighter and smaller than its predecessor.
The battery- powered device features a 12-in. LCD
touchscreen display, a built-in analyzer, and several connectivity
options.
In addition to Ethernet and USB interfaces, Renamic Neo
connects wirelessly to the Internet via cellular networks or
Wi-Fi, providing various data export functions. The state-ofthe-art
features give users freedom to export programmer
data to the hospital electronic health record (EHR) system
or digitally share the device interrogation report for remote
medical consultation.
The Renamic Neo by Biotronik reads and programs an implant wirelessly.
Renamic Neo offers LiveSupport, which allows clinicians to
share the programmer screen with, or grant programmer control
to, Biotronik technical support personnel at remote locations.
The control unit allows the physician or patient to read
out information such as battery status, heart rate, and other
parameters important to the functioning of the implanted device.
In developing this application, guidance from Schurter
Electronics played an important role.
The Renamic Neo is the world's first device that can read
and program the implant completely wirelessly, which requires
low electromagnetic radiation. Communication between the
Renamic Neo and the implanted device takes place wirelessly,
via a low-power radio signal. It is essential that there is no interference
in the frequency range of this signal. When developing
the application, electromagnetic compatibility (EMC) was
therefore an important issue from the start.
n Testing for Safety
In a special emission-free EMC chamber at Biotronik,
Schurter tested a number of controller types to see which solution
provided the lowest emission. Other components, such as
the LCD display, was also tested and optimized. With these results,
Schurter developed prototypes with the best-performing
components. The prototype components were then also tested
at Biotronik.
When the Renamic Neo went into production, Biotronik
asked Schurter to include an EMC test as standard in the production
process. This enabled Biotronik to officially measure
36
and confirm that their products met the medical EMC standard,
EN 60601-1-2. The device was tested in a shielded cabinet,
where no radiation could penetrate from the outside. The
product was placed in the cabinet, connected with cabling, and
switched on. An antenna in the cabinet captured all signals
around the frequency in question, and those went through a
coax cable to a spectrum analyzer outside the cabinet, which
measures the signals.
An algorithm determined an average value for these signals,
which must lie between 3 and 20 dB. Based on the requirements
set by Biotronik, Schurter redesigned the entire printed
circuit board to minimize exposure to emissions. Schurter
manufactures and distributes components for circuit protection
as well as connectors, switches, EMC products, and customer
specific components.
The Renamic Neo has now been in production for two years.
Schurter is currently supplying pre-series quantities, with a volume
goal to product a few thousand per year. Schurter is currently
fine-tuning the production process, where it is initially
focusing on the cost structure. Future areas for optimization
will include the following:
* Making improvements in production technology.
* Modifying materials or production methods to reduce costs.
Biotronik has already reduced production costs by more than
20 percent per unit over the last two years. The continuous optimization
of materials and production processes is ongoing.
This article was provided by Schurter Electronics B.V., Hardenberg,
The Netherlands. For more information, visit www.
schurter.com. Contact: info.nl@Schurter.com.
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Medical Design Briefs, January 2023
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Medical Design Briefs - January 2023

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