St Jude Medical SJMRFANT Merlin Antenna 3638 User Manual Merlin Antenna
St. Jude Medical Merlin Antenna 3638 Merlin Antenna
User Manual
St. Jude Medical AB Mall.nr / Template No.: SLB00120 REV 002
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Dokumentnamn / Title
RF Compliance input to Merlin™ Antenna Model 3638 User’s Manual
Avdelning / Dept. Utfärdare / Originator Ersätter / Supersedes
UP Magnus Johansson N/A
Avser / Concerns Säkerhetsklass / Classification Bilagor / Attachments
Project Intern / Internal Use N/A
Distribueras till / Distribution list
#VE_Unity_RF_Coreteam
Utgåva / Revision Revisionshistoria / Revisions History
001 First revision
1 PURPOSE & SCOPE .................................................................................................................................................. 2
2 INTRODUCTION / INTENDED USE ...................................................................................................................... 2
3 GENERAL INSTALLATION INSTRUCTION ...................................................................................................... 2
4 MERLIN ANTENNA TECHNICAL DATA ............................................................................................................ 3
5 ELECTROMAGNETIC COMPATIBILITY........................................................................................................... 4
6 RF OPERATING FREQUENCIES........................................................................................................................... 5
7 MERLIN ANTENNA SPECIFIC SYMBOLS.......................................................................................................... 6
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RF Compliance input to Merlin™ Antenna Model 3638 User’s Manual
St. Jude Medical AB Mall.nr / Template No.: SLB00120 REV 002
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1 Purpose & Scope
This document includes the User´s Manual input for the Merlin™ Antenna Model 3638 related to show
compliance of this device.
The final user manual for Merlin™ Antenna Model 3638 will be included in the manual for Merlin™ Patient
Care System Model 3650.
2 Introduction / Intended use
The Merlin™ Antenna Model 3638 is a dedicated radio antenna accessory designed to enable radio
frequency (RF) communication between the Merlin™ Patient Care System (Merlin PCS) Model 3650 and St.
Jude Medical® implantable devices with RF communication capability.
Figure 1. Merlin™ Antenna Model 3638
3 General installation instruction
1. Turn off the Merlin PCS.
2. Open the storage compartment door of the Merlin PCS and locate the RF Telemetry port. Connect the
cable from the Merlin Antenna to the RF Telemetry port labeled:
3. Place the Merlin Antenna on a flat surface aproximately 1-2m (2-6 ft) from the implantable device. The
front panel should face the device.
4. When the Merlin PCS is turned on, the status LEDs on the Merlin Antenna will light, indicating the unit is
powered and operational, see Figure 1.
5. When the Merlin PCS startup screen appears, the “Ready to connect to device” icon appears under the
Tools menu button, see Table 1.
Table 1. RF Telemetry icons
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6. Place the inductive telemetry wand over the patient’s device.
7. On Merlin PCS, select the Interrogate button. On the FastPath™ Summary Screen, the “Active RF
telemetry connection” icon appears under the Tools menu button, see Table 1.
8. The Telemetry Strength Indicators on the Merlin Antenna and the Merlin PCS indicate RF telemetry
communication between the Antenna and the device. A single lighted LED indicates telemetry is
established. A greater number of lighted LEDs indicates greater signal strength. If necessary, relocate
the Antenna for better communication.
9. Once RF telemetry is established, you may remove the inductive telemetry wand from the patient. Begin
the programming session.
CAUTION
The Model 3638 Antenna is only allowed to be connected to the Merlin PCS.
Position the Merlin Antenna at least 20 cm from the patient and from any device connected to the Merlin
PCS wireless port.
Do not use the Merlin Antenna if its enclosure is damaged.
A section related to trouble shooting RF will also be included in the User’s Manual for the Merlin Antenna:
Suboptimal RF communication: The Merlin PCS indicates the quality of the RF communication by the
telemetry strength indicator LEDs on both the programmer and the Merlin Antenna. Below is a list of potential
causes to suboptimal radio communication:
Possible Causes Solutions
The Merlin Antenna orientation/location is
suboptimal. Move or reorient the Antenna slightly. Make sure that
the front of the Antennafaces the implantable device.
People or objects interfere with the communication
between the Antenna and the device. Make sure that the space between the Antenna and
the device is free from interfering objects/people.
The Antenna is too far away from the device. Move the Antenna closer to the device.
Somone is holding the Antenna. Place the Antenna on a flat surface. Do not hold the
Antenna.
Other products in the vicinity are causing
electromagnetic interference (EMI). Power off or remove equipment that could cause
EMI.
The Antenna cable is wound around the Antenna. Make sure the Antenna cable is not wound around
the Antenna.
4 Merlin Antenna Technical data
Mechanical
Length 5.0 cm
Width 10.3 cm
Height 15.3 cm
Case material High-impact plastic
Cord to Merlin™ PSC 2.9 m
Electrical
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RF Compliance input to Merlin™ Antenna Model 3638 User’s Manual
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Input power (mains) Powered by Merlin™ PSC
Input voltage 5.0 V
Maximum current consumption 0.5 A
Expected Service Life 10 years
5 Electromagnetic Compatibility
The Merlin Antenna requires special precautions with regard to electromagnetic compatibility (EMC) and
should be used in accordance with the information provided in this manual.
The Merlin Antenna complies with the requirements of the international EMC standard IEC 60601-1-2:2001.
The Merlin Antenna is intended for use in the electromagnetic environment specified in Table 2 and Table 3.
WARNING
The Merlin Antenna is intended for use only by healthcare professionals. It complies with the limits for
medical devices contained in IEC/EN 60601-1-2:2001.
However, the Merlin Antenna may cause radio interference or may disrupt the operation of nearby
equipment. It may be necessary to mitigate this effect by reorienting or relocating the receiving device or
shielding the location.
Test Compliance Electromagnetic Environment – Guidance
RF Emission
CISPR 11 Group 1
The Merlin Antenna must emit electromagnetic
energy in order to perform its intended function.
This is identified by the RF Transmitter symbol
(Section 6). Nearby electronic equipment may be
affected.
Class A
The Merlin Antenna can be used in those
establishments that are directly connected to the
public low-voltage power supply network that
supplies commercial buildings and in domestic
environments under the supervision of healthcare
professionals.
Table 2. Guidance and manufacturer’s declaration – electromagnetic emissions
Test IEC 60601 Test Level
(Actual Level)* Electromagnetic Environment – Guidance
Electrostatic
Discharge
(ESD) IEC
61000-4-2
±6 kV contact (±6 kV
contact) ±8 kV air (±8
kV air) None
Power
Frequency
(50/ 60 Hz)
Magnetic Field
IEC 61000-4-8
3 A/m (3 A/m) None
Conducted RF
IEC 61000-4-6
Radiated RF
IEC 61000-4-3
3 Vrms (3 Vrms) 150
kHz to 80 MHz 3 V/m
(3 V/m) 80 MHz to 2.5
GHz
Interference may occur in the vicinity of equipment
marked with the RF Transmitter symbol (Section
6).
Table 3. Guidance and manufacturer’s declaration – electromagnetic immunity
* Figures in parentheses are the immunity compliance levels for each test.
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6 RF Operating Frequencies
Nearby equipment emitting strong fields can interfere with the RF telemetry, even if the other equipment
complies with CISPR emission requirements. The operating characteristics are as follows:
Merlin Antenna:
• MICS band: 402-405 MHz. The effective radiated power is below the limits as specified in:
- Europe: EN ETSI 301 839-2
- USA: FCC 47 CFR Part 95; 95.601-95.673 Subpart E, 95.1201-95.1219
• 2.45 GHz. The effective radiated power is below the limits as specified in:
- Europe: EN ETSI 300 328
- USA: FCC part 15.249
WARNING
This transmitter is authorized by rule under the Medical Implant Communications Service (part 95 of the
FCC Rules) and must not cause harmful interference to stations operating in the 400.150–406.000 MHz
band in the Meteorological Aids (i.e. transmitters and receivers used to communicate weather data), the
Meteorological Satellite, or the Earth Exploration Satellite Services and must accept interference that
may be caused by such aids, including interference that may cause undesired operation. This transmitter
shall be used only in accordance with the FCC Rules governing the Medical Implant Communications
Service. Analog and digital voice communications are prohibited. Although this transmitter has been
approved by the Federal Communications Commission, there is no guarantee that it will not receive
interference or that any particular transmission from this transmitter will be free from interference.”.
Note
Maintain a reasonable distance between other electronic equipment and the Merlin Antenna.
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7 Merlin Antenna specific symbols
RF Telemetry
Connection to the RF Telemetry port of Merlin PCS
Follow instructions for use
Intertek Listed US and Canada. Conforms to UL STD
60601-1. Certified to CAN/CSA C22.2 STD No.601.1
Interference may occur in the vicinity of this equipment.
Affixed to this device in accordance with European Council
Directive 90/385/EEC and 1999/5/EC.
Hereby, St. Jude Medical declares that this device is in
compliance with the essential requirements and other
relevant provisions of these Directives.
Serial number
FCC ID: RIASJMRFANT
FCC US