SJM MRI Activator Handheld Device User's Manual Model EX4000
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, LLC and its related companies. Pat. http://patents.sjm.com 2017 St. Jude Medical, LLC. All Rights Reserved.
Contents Description... 1 Intended Use... 1 Contraindications... 1 Adverse Events... 1 Warnings and Precautions... 1 Important Safeguards... 1 MRI Scan Requirements... 1 MR Conditional Pulse Generator Implant Location... 1 Using the Activator... 2 Check MRI Settings Status Using the SJM MRI Activator Handheld Device... 2 Enable the MRI Settings Using the SJM MRI Activator Handheld Device... 3 Disable the MRI Settings Using the SJM MRI Activator Handheld Device... 3 Battery Status... 3 Care, Cleaning, and Service... 3 Activator Lights... 3 Activator Sounds... 4 Technical Support... 4 Technical Information... 4 Accessories... 5 Electromagnetic Compatibility... 5 RF Operating Frequencies... 6 Storage and Operating Conditions... 6 Disposal... 6 Symbols... 6 i
Description The St. Jude Medical SJM MRI Activator handheld device (activator), Model EX4000, is an external device that uses radio waves to communicate with a St. Jude Medical MR Conditional implanted pulse generator. The activator enables and disables the pre-programmed MRI settings in the pulse generator. Intended Use The SJM MRI Activator handheld device is used to evaluate the status of, and to enable and disable, the previously stored MRI settings. The activator is intended for use with St. Jude Medical MR Conditional pulse generators. Contraindications There are no contraindications. Adverse Events There are no known adverse events. Warnings and Precautions Electromagnetic interference. The activator is not magnetic and has no moving parts. However, you should avoid equipment which generates a strong electromagnetic interference (EMI). EMI could interfere with communication between the activator and the implanted St. Jude Medical MR Conditional pulse generator. Moving away from the source of EMI or turning it off will usually allow the activator to return to its normal mode of operation. Communication equipment. Communication equipment such as microwave transmitters or high-power amateur transmitters may generate enough EMI to interfere with the performance of the activator if you are too close to the source of EMI. Wireless communication devices. Wireless communication devices such as computers that operate on a wireless network, handheld personal computers (PDA), cellular phones, and even cordless telephones may generate enough EMI to interfere with the performance of the activator if it is used too close to the source of EMI. Hospital and Medical equipment. A variety of standard hospital and medical equipment may generate enough EMI to interfere with the performance of the activator. These include, but are not limited to: blood pressure monitors, ECG equipment, external defibrillation equipment, x-ray machines. Office equipment. A variety of standard office equipment may generate enough EMI to interfere with the performance of the activator. These include, but are not limited to: desktop or laptop computers, fax machines, phone systems. Industrial equipment. A variety of industrial equipment may generate enough EMI to interfere with the performance of your activator. These include, but are not limited to: arc welders; induction furnaces; very large or defective electric motors; and internal combustion engines with poorly shielded ignition systems. Important Safeguards Basic safety precautions should always be followed when using electrical products, especially when children are present. These include the following: The activator is only for use by trained personnel. READ ALL INSTRUCTIONS BEFORE USING. DANGER! To reduce the risk of shock: - Do not place or store the activator where it can fall or be pulled into a tub or sink. - Do not place or drop the activator into water or other liquid. WARNING! To reduce the risk of burns, shock, fire, or injury to persons: - Use the activator only for its intended use as described in this manual. - Never operate the activator if it is not working properly, if it has been dropped or damaged, or if it has been dropped into water. Contact Technical Support (page 4) for service or replacement instructions. - Never drop or insert any object into any opening of the activator. - Do not use the activator near flammable substances. To reduce the risk of damage to the activator: - Do not transport or store the activator in a location where the temperature could reach higher than 55 C or lower than - 20 C. KEEP THESE INSTRUCTIONS. MRI Scan Requirements Patients with an implanted St. Jude Medical MR Conditional pacing system can have an MRI scan if the conditions for use, as described in the MRI Procedure Information document, are met. MR Conditional Pulse Generator Implant Location The St. Jude Medical MR Conditional pulse generator is implanted under the skin in the right- or left-pectoral region. 1
Figure 1. Implant location 1. Right-pectoral region 2. Left-pectoral region Using the Activator CAUTION Do not bring the SJM MRI Activator handheld device into Zone IV (MR scanner magnet room) as defined by the American College of Radiology. It is MR Unsafe. Doing so may cause injury or damage to the activator or MRI equipment. The SJM MRI Activator handheld device should be used only by qualified personnel. Use the activator to: Check the status of the MRI Settings (page 2) Enable the MRI Settings (page 3) Disable the MRI Settings (page 3) See also: Activator Lights (page 3) Activator Sounds (page 4) Figure 2. SJM MRI Activator handheld device 1. MR Status button 2. MRI Settings On button 3. Green LED 4. MRI Settings Off button 5. Red LED Check MRI Settings Status Using the SJM MRI Activator Handheld Device To check the status of the MRI Settings: 1.Place the activator over the implanted pulse generator. The activator should be touching the patient's clothing directly over the implanted pulse generator. See MR Conditional Pulse Generator Implant Location (page 1). 2.Press the MR Status button. - MRI Settings Enabled. The green LEDs illuminate continuously for 5 seconds. - MRI Settings Disabled. The red LEDs illuminate continuously for 5 seconds. 2
See also: Activator Lights (page 3) Activator Sounds (page 4) Enable the MRI Settings Using the SJM MRI Activator Handheld Device To enable the MRI Settings: 1.Place the activator over the implanted pulse generator. The activator should be touching the patient's clothing directly over the implanted pulse generator. See MR Conditional Pulse Generator Implant Location (page 1). 2.Press the MRI Settings On button. The LEDs may flash before they illuminate continuously. - MRI Settings Enabled. The green LEDs illuminate continuously for 5 seconds. - MRI Settings Disabled. The red LEDs illuminate continuously for 5 seconds. See also: Activator Lights (page 3) Activator Sounds (page 4) Disable the MRI Settings Using the SJM MRI Activator Handheld Device To disable the MRI Settings: 1.Place the activator over the implanted pulse generator. The activator should be touching the patient's clothing directly over the implanted pulse generator. See MR Conditional Pulse Generator Implant Location (page 1). 2.Press the MRI Settings Off button. The LEDs may flash before they illuminate continuously. - MRI Settings Disabled. The red LEDs illuminate continuously for 5 seconds. See also: Activator Lights (page 3) Activator Sounds (page 4) Battery Status The activator is designed to enable and disable a St. Jude Medical MR Conditional pulse generator's MRI Settings once a week. Under these conditions you can expect the activator battery to last about 36 months. More frequent use will deplete the battery more quickly. Care, Cleaning, and Service The activator is designed to be used as indicated; however, it is an electronic device and susceptible to many environmental stresses. Take care to avoid damaging the activator. If necessary, you can clean the outside of the activator with a cloth dampened with water. The handheld is classified as IPX0 because it is not waterproof. Do not immerse the activator in any liquid. There is no shut down procedure for the handheld. The batteries are not intended to be removed or replaced by the user. The activator does not contain any user-serviceable parts. Do not open the case. Preventive maintenance, including periodic safety checks, is not required for this activator. Do not modify the activator. If there is a problem with the activator, contact Technical Support (page 4). Activator Lights The activator uses the following light patterns to convey the status of the pulse generator MRI Settings: Table 1. Light patterns Action Response MRI Setting Status Press the MR Status button. The green LEDs illuminate continuously for 5 seconds. Enabled 3
Table 1. Light patterns Action Response MRI Setting Status Press the MR Settings On button. Press the MR Settings Off button. The red LEDs illuminate continuously for 5 seconds. The green LEDs flash and then illuminate continuously for 5 seconds. The green LEDs illuminate continuously for 5 seconds. The green LEDs flash and then the red LED illuminate continuously for 5 seconds. The red LEDs flash and then illuminate continuously for 5 seconds. The red LEDs illuminate continuously for 5 seconds. Disabled Enabled Enabled Disabled The implanted MR Conditional pacing system does not satisfy the conditions for an MR scan. Contact the referring physician for further instruction. Disabled Disabled Activator Sounds The activator emits the following sound patterns: Table 2. Sound patterns Action Response Explanation Any button is pressed. The activator emits a high-low sound. The activator is unable to establish communication with the pulse generator. Reposition the activator over the pulse generator and attempt the action again. No sound. The pulse generator is not a St. Jude Medical MR Conditional pulse generator. The activator battery is depleted. Return the activator to St. Jude Medical. See Disposal (page 6). Technical Support St. Jude Medical maintains 24-hour phone lines for technical questions and support: 1 818 362 6822 1 800 722 3774 (toll-free within North America) + 46 8 474 4147 (Sweden) For additional assistance, call your local St. Jude Medical representative. Technical Information NOTE: There are no user-serviceable parts in the activator. No calibration is required. Do not modify the activator. When used under normal operating conditions, this equipment generates no pollution. Table 3. Activator Specifications Specification Information Dimensions (cm) 7.1 x 5.6 x 1.8 Case material High-impact plastic Power source 1 cell; 3.6 V (nominal); Chemistry: Lithium Thionyl Chloride Battery longevity 3 years Audible output level 60 db (minimum) at 10.0 cm Classification with respect to electric shock Internally powered Protection from electric shock (IEC 60601-1) Type BF Protection against ingress of liquids Ordinary equipment Mode of operation Continuous 4
Accessories There are no accessories for this activator. Electromagnetic Compatibility The activator requires special precaution with regard to electromagnetic compatibility (EMC) and should be used in accordance with the information provided in this manual. The activator requires is intended for use in the electromagnetic environment specified in the tables below. The user should ensure that it is used in such an environment. WARNING The activator is intended for use in a hospital or medical clinic environment. It complies with the limits for medical devices contained in IEC/EN 60601-1-2:2007. However, the activator may cause radio interference or may disrupt the operation of nearby equipment. It may be necessary to evaluate this effect by reorienting or relocating the activator or shielding the location. Table 4. Guidance and manufacturer s declaration electromagnetic emissions Test Compliance Electromagnetic Environment - Guidance RF Emission CISPR 11 Group 1 The activator must emit electromagnetic energy in order to perform its intended function. Nearby electronic equipment may be affected. RF Emission CISPR 11 Class B The activator is suitable for use in all establishments, including domestic establishments. Table 5. Guidance and manufacturer s declaration electromagnetic immunity Test IEC 60601-1-2 Test Level (Actual Level) 1 Electromagnetic Environment - Guidance Electrostatic Discharge (ESD) IEC 61000-4-2 None Electrical fast transient/burst IEC 61000-4-4 None Power Frequency (50/60 Hz) Magnetic Field IEC 61000-4-8 None ±6 kv contact (±6 kv contact) ±8 kv air (±8 kv air) ±1 kv for input/output lines (±1 kv for input/output lines) 3 A/m (3 A/m) Table 6. Guidance and manufacturer s declaration electromagnetic immunity (conducted RF) Test IEC 60601-1-2 Test Level 2 Immunity Compliance Level Electromagnetic Environment - Guidance Radiated RF IEC 61000-4-3 3 V/m, 80 MHz to 2.5 GHz 3 V/m Portable and mobile RF communications equipment should be used no closer to the activator than the recommended separation distance. 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, should be less than the compliance level in each frequency range. Interference may occur in the vicinity of equipment marked with the following symbol: 1 Figures in parentheses are the immunity compliance levels for each test. 2 At 80MHz and 800MHz, the higher frequency range applies. 5
Table 6. Guidance and manufacturer s declaration electromagnetic immunity (conducted RF) Test IEC 60601-1-2 Test Level 2 Immunity Compliance Level Electromagnetic Environment - Guidance Electromagnetic site survey- 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 of the location in which the activator is used exceeds the applicable RF compliance level above, the activator should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as re-orienting or relocating the activator. RF Operating Frequencies Nearby or hidden equipment emitting strong magnetic fields, such as Radio-Frequency IDentification (RFID) emitters, other medical and radio devices, etc., can interfere with inductive and RF communication of the activator, even if the other equipment complies with applicable emission requirements. If interference occurs, you can minimize its effect by reorienting or relocating the activator or by shielding its location. The operating characteristics of the activator are as follows: Inductive Telemetry - RF Transmission Carrier frequency at 60 khz (inductive telemetry). - RF Reception Centered at 60 khz (inductive telemetry). NOTE: Maintain a reasonable distance between other electronic equipment and the device. Storage and Operating Conditions Table 7. Storage and operating conditions Property Storage Operating Minimum Temperature ( C) -20 0 Maximum Temperature ( C) 55 50 Minimum Humidity (% non-condensing) 5 10 Maximum Humidity (% non-condensing) 95 95 Disposal Return the device to St. Jude Medical at the end of its operating life or dispose of the device according to your local regulations. Contact your local St. Jude Medical representative for information on disposal. The crossed-out trash can symbol marked on the device 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. Symbols The following symbols may be used on the activator or on the product packaging. Table 8. Symbols Symbol Definition MR Status button MR Settings On button MR Settings Off button In MRI Settings? Yes No 6
Table 8. Symbols Symbol Definition Place the SJM MRI Activator over the implanted MR Conditional device. Press the MRI Settings On button before the MRI scan. Press the MRI Settings Off button after the MRI scan. Do not use in MRI scan room. Caution, Consult Accompanying Documents European conformity, affixed according to the relevant provisions of AIMD directive 90/385/EEC and RE directive 2014/53/EU Annex II. Hereby, St. Jude Medical declares that this device complies with the essential requirements and other relevant provisions of these directives. The full text of the European Union RE directive 2014/53/EU declaration of conformity is available at the following internet address: www.sjmglobal.com/euconformity. This product operates between 9 and 200 khz with an H-field strength of less than 25 dbµa/m at 10 m. Date of Manufacture Manufacturer Country of manufacture; BE- Belgium, MY- Malaysia, US- United States Lot number Serial number Use by Temperature limitations Humidity limitation Authorized EC Representative in the European Community The device contains a battery and the label is affixed to this device in accordance with European Council Directives 2002/96/EC and 2006/66/EC. These directives call for separate collection and disposal of electrical and electronic equipment and batteries. 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. Return the device to St. Jude Medical at the end of its operating life. Type BF equipment Prescription only Interference may occur in the vicinity of this equipment Consult instructions for use TUV Listed, US and Canada. Pouch 7
Table 8. Symbols Symbol Definition Activator 8
Manufacturer: St. Jude Medical Cardiac Rhythm Management Division 15900 Valley View Court Sylmar, CA 91342 USA +1 818 362 6822 Manufacturing Site: St. Jude Medical Puerto Rico LLC Lot A Interior - #2 Rd Km. 67.5 Santana Industrial Park Arecibo, PR 00612 USA sjm.com European Authorized Representative: St. Jude Medical Coordination Center BVBA The Corporate Village Da Vincilaan 11 Box F1 1935 Zaventem Belgium +32 2 774 68 11 Manufacturing Site: St. Jude Medical Operations (M) Sdn. Bhd. Plot 102, Lebuhraya Kampung Jawa, Bayan Lepas Industrial Zone 11900 Penang Malaysia Australian Sponsor: St. Jude Medical Australia Pty. Limited 17 Orion Road Lane Cove NSW 2066 Australia April 2017 ARTEN100159772 A