Nanostim Programmer Link S1LINK. Instructions for Use

Transcription

1 Nanostim Programmer Link S1LINK Instructions for Use

2 Covered by one or more of the following US patents: 7,945,333, 8,295,939, 8,352,025, 8,457,742 Unless otherwise noted, indicates that the name is a trademark of, or licensed to, St. Jude Medical or one of its subsidiaries. ST. JUDE MEDICAL and the nine-squares symbol are trademarks and service marks of St. Jude Medical, Inc. and its related companies St. Jude Medical, Inc. All Rights Reserved.

3 Contents Description... 1 Intended Use... 1 Contraindications... 1 Warning... 1 Precautions... 2 Potential Adverse Events... 2 Package Contents... 2 Compatible Devices... 2 Communication Between Pacemaker and Programmer... 2 Classification... 3 Skills, Training, and Knowledge... 3 Start-Up Procedure... 3 Setup for Nanostim Leadless Pacemaker Implant or Retrieval (Operating Room/Cath Lab/EP Lab)... 3 Nanostim Leadless Pacemaker Follow-Up (Office)... 4 Connecting the Nanostim Programmer Link... 5 Connecting the Patient Cable to the Patient Using St. Jude Medical Cable Model Starting the Nanostim Programmer Link... 6 Operating Instructions... 6 Messages... 6 Recommended Replacement Time (RRT)... 7 Assessing RRT Without a Nanostim Programmer Link... 7 Printer Paper Out Message... 7 Device Not Supported Message... 7 Loss of Link Message... 7 Shutdown Procedure... 7 Nanostim Programmer Link Cleaning and Disinfection... 7 Patient Cable, Cleaning and Disinfection... 7 Environmental Protection... 8 Replacement Parts... 8 Nanostim Programmer Link Mount Installation... 8 Electrode Location and Boot Instructions Sticker... 9 Transport and Storage Conditions... 9 Use Conditions... 9 Technical Characteristics of the Nanostim Programmer Link... 9 Servicing... 9 Maintenance Instructions... 9 Electromagnetic Compatibility Technical Support Symbols CE Mark Date i

4

5 Description The Nanostim Programmer Link communicates with an implanted Nanostim Leadless Pacemaker (LP) via conducted communication through skin electrodes. Safe, high frequency electrical pulses are sent between the LP and programmer 1 to program and interrogate the LP. The Nanostim Programmer Link uses the skin electrodes to record a patient s ECG waveform. It also utilizes a St. Jude Medical patient cable and CE-marked skin electrodes. In normal use it is powered via a St. Jude Medical Merlin Patient Care System (PCS) Model 3650 s USB port. The Nanostim Programmer Link includes an embedded flash drive that contains the software that boots and executes on the Merlin PCS. Figure 1. The Nanostim Programmer Link 1. LED lights illuminate when the Nanostim Programmer Link is receiving appropriate power. 2. Patient connector: Connect to the patient using the patient cable and skin electrodes. 3. USB connector: Connect to the St. Jude Medical Merlin PCS programmer using the USB cable. 4. Auxiliary power connector: Not required in normal use. Auxiliary power adapter is not supplied. 5. The mating slot in the center of the Nanostim Programmer Link slides on a mounting plate affixed by an adhesive decal to the back of the Merlin PCS. Intended Use The Nanostim Programmer Link is intended for use in conjunction with a St. Jude Medical Merlin PCS Model 3650 programmer to interrogate and program the Nanostim Leadless Pacemaker (LP) and to monitor ECG waveforms for observing LP function. It is intended for use by trained healthcare professionals in a hospital or healthcare setting. It is not intended for use in domestic establishments. Contraindications There are no known contraindications for use of the Nanostim Programmer Link. Warning Warning: Do not use the ECG provided by the Nanostim Programmer Link for diagnosis of any physiological condition, because it is intended only for observing Nanostim Leadless Pacemaker function. Warning: Do not attempt to modify the Nanostim Programmer Link or its accessories, because this could adversely affect its operation, and/or could result in increased electromagnetic emissions or decreased immunity. Warning: Do not attempt to service the Nanostim Programmer Link or its accessories. Contact St. Jude Medical for return or replacement. Refer to the Electromagnetic Compatibility (EMC) (page 10) section for instructions regarding any significant risks of reciprocal interference posed by the presence of the Nanostim Programmer Link during specific investigations or treatments, and for 1 The Nanostim Programmer Link is used with a St. Jude Medical Merlin Patient Care System (Merlin PCS) Model Merlin PCS Model 3650 is a portable, dedicated programming system designed to interrogate, program, display data, and test St. Jude Medical implantable devices, but which can alternatively perform similar functions with a Nanostim Leadless Pacemaker when used with the Nanostim Programmer Link as described herein. Consult the Merlin PCS User's Manual for further information. 1

6 information regarding potential electromagnetic or other interference between the Nanostim Programmer Link and other devices together with advice on ways to avoid or minimize such interference. The Nanostim Programmer Link requires special precautions regarding electromagnetic compatibility (EMC) and needs to be installed and put into service according to the information in the Electromagnetic Compatibility (page 10) section. Other warnings or safety notices that apply only to a specific instruction or action precede the instruction to which they apply. Precautions Caution: Do not drop the Nanostim Programmer Link. If inadvertently dropped, or if the Nanostim Programmer Link appears damaged, do not use. Return to St. Jude Medical for testing. Caution: If labels or instructions appear altered or illegible do not use the Nanostim Programmer Link. Contact St. Jude Medical Technical Support for replacement. Caution: To reduce the risk of diaphragmatic stimulation, implant the Nanostim Leadless Pacemaker in a location that does not cause diaphragmatic stimulation at maximum output. Potential Adverse Events There are no known potential adverse effects for use of the Nanostim Programmer Link. Package Contents Packaging contains: Instructions for use Patient Cable, 3626 USB Cable, PC Link mount for Merlin TM PCS Model Optional Mouse, Black Optical w/scroll Wheel, with PS/2 and USB Connector. PC (The mouse may be connected to an available Merlin PCS USB port and used as an input device instead of, or in addition to, the Merlin PCS touch screen.) The Nanostim Programmer Link is not supplied with skin electrodes. Use CE-marked ECG electrodes. Compatible Devices The Nanostim Programmer Link communicates with an implanted Nanostim Leadless Pacemaker via conducted communication through skin electrodes. The Nanostim Programmer Link operates only with the Nanostim Leadless Pacemaker. The Nanostim Programmer Link operates only when connected to a St. Jude Medical Merlin PCS Model Do not attempt to use the Nanostim Programmer Link with other devices, because this could result in no programming, mis-programming, or damage to the devices. Communication Between Pacemaker and Programmer To reduce size and increase longevity, the Nanostim Leadless Pacemaker communicates with the Nanostim Programmer Link via conducted communication. As with all communication methods, this can be affected by device orientation and electromagnetic interference. The Nanostim Programmer Link indicates the quality of the conductive communication by the telemetry strength indicator LEDs displayed on the Merlin PCS. Caution: Conducted communication can cause artifact to appear on ECG displays, including the Nanostim Programmer Link's ECG display. Table 1. Guidance for optimizing conducted communication Possible causes for suboptimal communication Nanostim Programmer Link surface electrode orientation/location is suboptimal. Other devices in the vicinity are causing electromagnetic interference (EMI). The surface electrodes are attached to the Merlin PCS. Solutions Move or reorient the Nanostim Programmer Link surface electrodes. Clean the skin prior to application of Nanostim Link surface electrodes. Power off or remove equipment that could cause EMI. Connect the surface electrode cable to the Nanostim Programmer Link. 2

7 Classification The Nanostim Programmer Link provides protection against electrical shock per IEC Class II, with Type BF defibrillationproof applied parts. Protection against water or particulate matter is classified IPX0. The Nanostim Programmer Link is not intended for use in an oxygen-rich environment. The Nanostim Programmer Link is classified for continuous operation. Following exposure to defibrillation voltage, the Nanostim Programmer Link will return to normal function within 30 seconds. Skills, Training, and Knowledge The Nanostim Programmer Link is intended for use by or under the direction of a physician. Read all accompanying documents and labels before use. Do not use if accompanying documents or labels are illegible or appear damaged; contact St. Jude Medical Technical Support for replacement. Start-Up Procedure The Nanostim Programmer Link is used in three situations: Nanostim Leadless Pacemaker implant, follow-up, and retrieval. The sections below describe the start-up procedure for using the Nanostim Programmer Link, comprising: Setup for Nanostim Leadless Pacemaker implant or retrieval Setup for Nanostim Leadless Pacemaker follow-up Connecting the Nanostim Programmer Link Connecting the patient cable (the applied part) to the patient Starting the Nanostim Programmer Link Setup for Nanostim Leadless Pacemaker Implant or Retrieval (Operating Room/Cath Lab/EP Lab) Refer to the diagram below for an example of positions of physician, patient, and operator. Connect the Nanostim Programmer Link as explained in Connecting the Nanostim Programmer Link (page 5). Place the skin electrodes on the patient following instructions provided in Connecting the Patient Cable to the Patient Using St. Jude Medical Cable Model (page 6) Modify the electrode placement as necessary to accommodate the sterile field. Turn off external defibrillators and ablation generators because they may interfere with communication. 3

8 Figure 2. Setup for LP implant or retrieval 1. Physician 2. Patient 3. Patient Cable 4. Nanostim Programmer Link and Merlin PCS 5. Programmer Operator Nanostim Leadless Pacemaker Follow-Up (Office) Refer to the diagram below for an example of positions of physician, patient, and operator. Connect the Nanostim Programmer Link as explained in Connecting the Nanostim Programmer Link (page 5). Place the skin electrodes on the patient following instructions provided in Connecting the Patient Cable to the Patient Using the St. Jude Medical Cable Model 3626 (page 6). 4

9 Figure 3. LP Follow-Up (Office) Configuration 1. Patient 2. Patient Cable 3. Nanostim Programmer Link and Merlin PCS 4. Programmer Operator Connecting the Nanostim Programmer Link Slide the Nanostim Programmer Link onto the Merlin PCS using the mount located behind the touchscreen. Please refer to Nanostim Programmer Link Mount Installation (page 8) instructions to install the mount on the Merlin PCS. Connect the USB cable to the Merlin PCS via the USB port located on the left side of the programmer as viewed from the front (looking at touchscreen) and to the Nanostim Programmer Link (Port #3 shown below). Figure 4. Merlin PCS Plug the patient cable into the Nanostim Programmer Link. 5

10 Connecting the Patient Cable to the Patient Using St. Jude Medical Cable Model 3626 Place skin electrodes on the torso in the positions shown at left. Clip each terminal of the patient cable to the appropriate skin electrode based on the terminal color shown at left. Red = R Yellow = L Green = F Black = N White = C Please note that the non-standard electrode locations described are required for communication with the Nanostim Leadless Pacemaker. Starting the Nanostim Programmer Link Simultaneously press and hold down the 25 mm and 50 mm chart speed buttons on the Merlin PCS while turning on its main power supply. Keep the buttons pressed down until the Merlin PCS beeps. Wait for the programmer software to load. This can take more than 1 minute. When ECG traces begin to sweep, the Nanostim Programmer Link is ready to use. Operating Instructions The frequently used functions of the Nanostim Programmer Link are: Interrogate Program Monitor ECG Perform these functions with the Nanostim Programmer Link in a fashion similar to performing these functions for St. Jude Medical VVIR pacemakers using the Merlin PCS. Step by step instructions for these functions with the Merlin PCS are included in the Nanostim Leadless Pacemaker Instructions for Use. If the touchscreen of the Merlin PCS becomes inoperable during programming of the Nanostim Leadless Pacemaker implant, power off the Merlin PCS using its main power button and reboot according to the instructions in Starting the Nanostim Programmer Link (page 6). If the touchscreen continues to be inoperable after reboot, replace the Merlin PCS with a new unit and proceed with the procedure. IMPLANTING THE NANOSTIM LEADLESS PACEMAKER WITHOUT A NANOSTIM PROGRAMMER LINK: If a Nanostim Programmer Link is not available, the Nanostim Leadless Pacemaker can still be implanted normally. Capture can be assessed using a standard pacemaker magnet and observing the patient s ECG on a monitor. At a future follow-up an Nanostim Programmer Link can be used to customize the Nanostim Leadless Pacemaker programming, if desired. NANOSTIM LEADLESS PACEMAKER FOLLOW-UP WITHOUT A NANOSTIM PROGRAMMER LINK: If a Nanostim Programmer Link is not available, Recommended Replacement Time (RRT) condition can be assessed using a standard pacemaker magnet. See Assessing RRT Without a Nanostim Programmer Link (page 7). Messages This section describes alarms and other messages. Alarms are important messages that alert the user of the Nanostim Programmer Link that a potential or actual hazard exists. Alarms do not necessarily require immediate attention. 6

11 Recommended Replacement Time (RRT) At interrogation, the Nanostim Programmer Link will indicate an alarm when the Nanostim Leadless Pacemaker reports that it has reached RRT. When a pacemaker reaches its RRT, it will soon reach its end of service (EOS). The pacemaker should be replaced expeditiously. Once the RRT alarm is indicated by the Nanostim Programmer Link, it must be acknowledged before continuing. The RRT alarm is a low priority alarm because it does not indicate an immediate hazard. For additional information on RRT, see the Nanostim Leadless Pacemaker Instructions for Use. The Nanostim Programmer Link has no provision for the user to verify operation of this alarm. Assessing RRT Without a Nanostim Programmer Link If a Nanostim Programmer Link is not available, a magnet can be used to determine if the device has reached RRT. Place a standard pacemaker magnet over the device implant site. Observe the patient s ECG for asynchronous pacing. Measure the pacing intervals. In RRT the device will pace at 100 min-1 for 8 cycles then pace at 65 min-1 for as long as the magnet is detected. Not in RRT, the device will pace at 100 min-1 for 8 cycles then pace at 90 min-1 for as long as the magnet is detected. The RRT condition is determined by the device s internal self-check mechanism. Detection of RRT at a follow-up means that the device could have reached RRT at any time since the prior follow-up. Printer Paper Out Message This message appears when the Merlin PCS is out of printer paper. For instructions on how to load more paper into the Merlin PCS, refer to the Merlin PCS reference manual. For additional printer paper, contact St. Jude Medical. Device Not Supported Message This message appears when the Nanostim Programmer Link software detects that the device is not supported. If this message persists following confirmation of setup and re-interrogation, contact St. Jude Medical Technical Support for further support. Loss of Link Message This message appears when the Nanostim Programmer Link cannot communicate with the device without detecting data errors. Refer to the troubleshooting tips listed in Communication Between Pacemaker and Programmer (page 2) and Electromagnetic Compatibility (page 10). If this message persists even after troubleshooting, the Nanostim Programmer Link could require replacement. Refer to Operating Instructions (page 6) for information on how to implant or follow-up a patient with an Nanostim Leadless Pacemaker without using a Nanostim Programmer Link. Contact St. Jude Medical Technical Support for further help. Shutdown Procedure After completion of interrogation and programming, simply turn off the Merlin PCS power switch. Nanostim Programmer Link Cleaning and Disinfection The Nanostim Programmer Link may not be sterilized by any method. The Nanostim Programmer Link may be cleaned and disinfected using a lint-free wipe and any of the following solvents: Clean Water Water mixed with mild detergent A solution of 50% IPA and 50% clean water Care should be taken not to expose the device excessively to fluids. Patient Cable, Cleaning and Disinfection The patient cable may not be sterilized by any method. The patient cable may be cleaned and disinfected using a lint-free wipe and any of the following solvents: Clean water Water mixed with mild detergent A solution of 50% IPA and 50% clean water Care should be taken not to expose the patient cable excessively to fluids. 7

12 Environmental Protection Return the Nanostim Programmer Link and accessories to St. Jude Medical at the end of their operating lives. The crossed-out trash can symbol marked on the devices indicates that St. Jude Medical complies with the European Union s Waste Electrical and Electronic Equipment (WEEE) directive. That directive calls for separate collection and disposal of hazardous waste from electrical and electronic equipment. Sorting such waste and removing it from other forms of waste lessens the contribution of potentially toxic substances into municipal disposal systems and into the larger ecosystem. Replacement Parts Contact St. Jude Medical Technical Support to obtain the following replacement parts: Table 2. Replacement parts Model Number S1LINK A2LINK Description 3626 Patient Cable 3650 Merlin PCS Complete Nanostim Programmer Link kit including: Patient Cable Nanostim Programmer Link Mount USB Cable with Ferrite Instructions for Use Boot and Electrode Sticker Nanostim S1LINK Accessories (OUS) including: Nanostim Programmer Link Mount USB Cable with Ferrite Boot and Electrode Sticker Nanostim Programmer Link Mount Installation This section provides the instructions for installing the Nanostim Programmer Link Mount on the Merlin PCS. The Mount allows the Nanostim Programmer Link to be mounted and removed from the back of the Merlin PCS. 1. Slide the Mount into the slot at the back of the Nanostim Programmer Link in the orientation shown below. 2. Remove the adhesive backing from the Mount. 3. Carefully place the Nanostim Programmer Link on the back of the Merlin PCS as shown. Press the Nanostim Programmer Link to the Merlin PCS firmly for 10 seconds to allow the adhesive to bond. 4. The Nanostim Programmer Link can now be mated and removed from the back of the Merlin PCS. Figure 5. Nanostim Programmer Link mated to the back of the Merlin PCS 8

13 Electrode Location and Boot Instructions Sticker This section provides the instructions for installing the electrode location and boot instructions sticker on the Merlin PCS. 1. Apply the sticker to the Merlin PCS in the location shown. Figure 6. Sticker applied Transport and Storage Conditions The permissible environmental conditions for transport and storage are: Between -40Cº and 55Cº Between 25% and 93% RH Use Conditions The Nanostim Programmer Link is intended for use in a controlled environment typical of a hospital or medical clinic. Between 15Cº and 25Cº Between 25% and 93% RH Technical Characteristics of the Nanostim Programmer Link For technical characteristics of measurements performed by the Nanostim Leadless Pacemaker (such as R-wave, Battery Voltage and Lead Impedance) refer to the Nanostim Leadless Pacemaker Instructions for Use. ECG display is solely for the purpose of observing the leadless pacemaker's function and not to be used for diagnosis of any physiological condition. As such, its range, accuracy and precision are not specified and should not be used for patient assessment. The Nanostim Programmer Link is powered from one source (listed below). The Nanostim Programmer Link is isolated from the mains power by this device. St. Jude Medical Merlin PCS Model 3650 (for normal use) The Nanostim Programmer Link is approximately 4.5" x 9.5" x 1.5". Its case is made of plastic. The Nanostim Programmer Link weighs approximately one pound. Servicing The Nanostim Programmer Link is not intended to be nor does it require field service. Contact St. Jude Medical Technical Support for return or replacement of defective or malfunctioning unit. Maintenance Instructions For all maintenance other than periodic safety testing, please contact St. Jude Medical Technical Support. Periodic safety testing may be performed according to the procedures of the institution where the Nanostim Programmer Link is used. St. Jude Medical recommends that safety testing be evaluated at least annually. St. Jude Medical performs the tests described below. Required equipment is: 9

14 Nanostim Programmer Link Merlin PCS Model 3650 with AC power cord USB Cable Patient Cable Safety Analyzer Patient leakage current should be less than 100 μa in normal condition and less than 500 μa in single fault condition when measured with an appropriate measuring device per IEC standard. Patient auxiliary current should be less than 100 μa in normal condition and less than 500 μa in single fault condition when measured with an appropriate measuring device per IEC standard. Mains-on applied part current should be less than 5000 μa when measured with an appropriate measuring device per IEC standard. Electromagnetic Compatibility The Nanostim Programmer Link needs special precautions regarding EMC and needs to be installed and put into service according to the EMC information provided in this document. Portable and mobile RF communications equipment can affect the Nanostim Programmer Link. Use only the accessories listed is this document (see instructions for use section). Use of accessories other than those specified may result in increased emissions or decreased immunity of the Nanostim Programmer Link. Other than the St. Jude Medical Merlin PCS Model 3650 programmer, the Nanostim Programmer Link should not be used adjacent to or stacked with other equipment. If adjacent or stacked use is necessary, the Nanostim Programmer Link should be observed to verify normal operation in the configuration in which it will be used. The Nanostim Programmer Link has been tested with the St. Jude Medical Merlin PCS Model 3650 programmer as described in this section. To be free from unacceptable risk as determined by the manufacturer (essential performance), the Nanostim Programmer Link: Provides correct communication between the implant and the user interface, or Indicates to the user that the Nanostim Programmer Link cannot provide correct communication at this time - A non-functional display (blank or frozen), or an appropriate error message, can provide the required indication - In the presence of such an indication, essential performance requires: 1. Providing instructions to obtain correct communication, and 2. If compliance with the instructions does not result in correct communication, instructing the user to verify RRT with alternative means. 3. Accompanying documents, the programmer display, or both can provide the required instructions. The Nanostim Programmer Link needs to receive electromagnetic energy from the Nanostim Leadless Pacemaker for it to function. The Nanostim Programmer Link receiver operates between 420 and 580 khz. This is an "exclusion band" as defined by IEC Table 3. Guidance and manufacturer's declaration electromagnetic emissions The Nanostim Programmer Link is intended for use in the electromagnetic environment specified below. The customer or the user of the Nanostim Programmer Link should assure that it is used in such an environment. Emissions Test Compliance Electromagnetic environment - guidance RF emissions CISPR 11 Group 2 The Nanostim Programmer Link must emit electromagnetic energy in order to perform its intended function. Nearby electronic equipment may be affected. RF emissions Class A The Nanostim Programmer Link is suitable for use in all establishments other CISPR 11 than domestic and those directly connected to the public low-voltage power supply network that supplies buildings used for domestic purposes. Harmonic emissions Not Applicable IEC Voltage fluctuations/ flicker Not Applicable emissions IEC Table 4. Guidance and manufacturer's declaration - electromagnetic immunity The Nanostim Programmer Link is intended for use in the electromagnetic environment specified below. The customer or user of the Nanostim Programmer Link should assure that it is used in such an environment. 10

15 Table 4. Guidance and manufacturer's declaration - electromagnetic immunity IMMUNITY test IEC test level Compliance level Electromagnetic environment - guidance Electrostatic discharge (ESD) IEC Electrical fast transient/burst IEC Surge IEC Voltage dips, short interruptions and voltage variations on power supply input lines IEC Power frequency (50/60 Hz) magnetic field IEC ±6 kv contact ±8 kv air ±2 kv for power supply lines ±1 kv for input/output lines ±1 kv line(s) to line(s) ±2 kv line(s) to earth <5 % UT (>95 % dip in UT) for 0,5 cycle 40 % UT (60 % dip in UT) for 5 cycles 70 % UT (30 % dip in UT) for 25 cycles <5 % UT (>95 % dip in UT) for 5 s ±6 kv contact ±8 kv air ±2 kv for power supply lines ±1 kv for input/output lines ±1 kv line(s) to line(s) ±2 kv line(s) to earth <5 % UT (>95 % dip in UT) for 0,5 cycle 40 % UT (60 % dip in UT) for 5 cycles 70 % UT (30 % dip in UT) for 25 cycles <5 % UT (>95 % dip in UT) for 5 s Floors should be wood, concrete or ceramic tile. If floors are covered with synthetic material, the relative humidity should be at least 30%. Mains power quality should be that of a typical commercial or hospital environment. Mains power quality should be that of a typical commercial or hospital environment Mains power quality should be that of a typical commercial or hospital environment. If the user of the Nanostim Programmer Link requires continued operation during power mains interruptions, it is recommended that the Nanostim Programmer Link be powered from an uninterruptible power supply or a battery. 3 A/m 3 A/m Power frequency magnetic fields should be at levels characteristic of a typical location in a typical commercial or hospital environment. NOTE UT is the a.c. mains voltage prior to application of the test level. Table 5. Guidance and manufacturer s declaration electromagnetic immunity The Nanostim Programmer Link is intended for use in the electromagnetic environment specified below. The customer or the user of the Nanostim Programmer Link should assure that it is used in such an environment. IMMUNITY Test Conducted RF IEC Radiated RF IEC IEC TEST LEVEL 3 Vrms 150 khz to 80 MHz 3 V/m 80 MHz to 2,5 GHz Compliance Electromagnetic environment - guidance level 3 Vrms Portable and mobile RF communications equipment should be used no closer to any part of the Nanostim Programmer Link, including cables, than the recommended separation distance calculated from the equation applicable to the frequency of the 3 V/m transmitter Recommended separation distance 80 MHz to 800 MHz 800 MHz to 2.5 GHz where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer and d is the recommended separation distance in meters (m). Field strengths from fixed RF transmitters, as determined by an electromagnetic site survey, a should be less than the compliance level in each frequency range. b Interference may occur in the vicinity of equipment marked with the following symbol: 11

16 Table 5. Guidance and manufacturer s declaration electromagnetic immunity The Nanostim Programmer Link is intended for use in the electromagnetic environment specified below. The customer or the user of the Nanostim Programmer Link should assure that it is used in such an environment. IMMUNITY Test IEC TEST LEVEL Compliance level Electromagnetic environment - guidance NOTE 1 At 80 MHz and 800 MHz, the higher frequency range applies. NOTE 2 These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people. a Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy. To assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey should be considered. If the measured field strength in the location in which the Nanostim Programmer Link is used exceeds the applicable RF compliance level above, the Nanostim Programmer Link should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as re-orienting or relocating the Nanostim Programmer Link. b Over the frequency range 150 khz to 80 MHz, field strengths should be less than 3 V/m. Table 6. Recommended separation distances between portable and mobile RF communications equipment and the Nanostim Programmer Link The Nanostim Programmer Link is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the Nanostim Programmer Link can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the Nanostim Programmer Link as recommended below, according to the maximum output power of the communications equipment. Rated maximum output power of transmitter (W) Separation distance according to frequency of transmitter (m) 150 khz to 80 MHz 80 MHz to 800 MHz 800 MHz to 2,5 GHz 0,01 0, For transmitters rated at a maximum output power not listed above, the recommended separation distance d in meters (m) can be estimated using the equation applicable to the frequency of the transmitter, where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer. NOTE 1 At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies. NOTE 2 These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people. Technical Support St. Jude Medical maintains 24-hour phone lines for technical questions and support: (toll-free within North America) (Sweden) For additional assistance, call your local St. Jude Medical representative. 12

17 Symbols Table 7. Symbols Symbol Description Contents quantity Interference may occur in the vicinity of this equipment Date of Manufacture Manufacturer Do not use if package is damaged Keep dry Type BF applied part Defibrillation-proof Direct current Follow the instructions for use Follow instructions for use on this website Reorder number Lot number Authorized Representative in the European Community Keep away from sunlight Consult instructions for use Follow instructions for use on this website Sterilized using ethylene oxide Serial number Affixed to this device in accordance with European Council Directive 2012/19/EU. Refer to Environmental Protection (page 8). Polarity (positive terminal is inner conductor) Affixed in accordance with European Council Directive 90/385/EEC. Hereby, St. Jude Medical declares that this device is in compliance with the essential requirements and other relevant provisions of these Directives. Temperature limitations Humidity limitation 13

18 Table 7. Symbols Symbol Description Made in USA User's manual CE Mark Date Table 8. Year in which the CE mark was awarded. Model Year S1LINK ,

19

20

21

22 Manufacturer: St. Jude Medical Valley View Court Sylmar, CA USA European Authorized Representative: St. Jude Medical Coordination Center BVBA The Corporate Village Da Vincilaan 11 Box F Zaventem Belgium sjm.com November 2014 Art /B DC rev B