User's Manual
Table Of Contents
- Introduction
- Indications
- Intended Use
- Contraindications
- Technical Support
- Features
- Setup Instructions
- Maintenance and Troubleshooting
- Technical Data
- Symbols
- Symbols
26
Extension cord 1.22 m (4.0 ft)
Merlin™ Antenna Specifications
The Merlin™ Antenna Model 3638 is Class I medical equipment
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.
Mechanical
Length 5.0 cm (2.0 in)
Width 10.3 cm (4.0 in)
Height 15.3 cm (6.0 in)
Case material High-impact plastic
Electrical
Input power (mains) Powered by Merlin™ PCS
Input voltage 5.0 V
Maximum power consumption
0.5 A
Merlin™ Antenna Cable
Cable to Merlin™ PCS 2.9 m (9.5 ft)
Essential Performance
The Merlin™ PCS provides access to SJM active implantable medical devices (pacemakers, CRT-
Ps, ICDs, and CRT-Ds) but does not provide therapy. All therapy is delivered via the implanted
device.
The Merlin PCS communicates with SJM implantable devices enabling operations such as
programming, and the sending and retrieval of data between the Merlin PCS and the implanted
device.
The Merlin PCS provides visual and mechanical interfaces to medical professionals so they may
assess patient conditions and enable and assess the functioning of the implanted device.
NOTE: For single fault conditions, see Troubleshooting (page 22).
Data Security
St. Jude Medical takes a broad and deep approach to ensuring the safety, security and privacy of
the patient information and data on our devices and systems connecting patients to healthcare
providers and clinics. Patients, clinical staff, and hospital IT staff do not need to configure the
pulse generator or take any special action, for example firewall use, to safeguard patient
information and device data.
The Merlin PCS programmer logs security events, for example a failed installation of
programmer software, and stores these log files on disk. These files can then be analyzed by
St. Jude Medical personnel during system forensics. They are not meant to be analyzed by
the clinic's information technology personnel.
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The Merlin PCS, RF antenna and Merlin PSA comply with IEC 60601-1: 2005, ANSI/AAMI ES 60601-1: 2005 as well as
UL60601-1: 2003, and CAN/CSA-C22.2 No. 601.1-M90, CAN/CSA-C22.2 No. 60601-1: 2008 (Inclusion of ANSI/AAMI ES 60601-
1:2005 does not infer acceptance of the standard by OSHA).