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7 

 

Indications for Use 

The St. Jude Medical™ deep brain stimulation system 

is indicated for the following conditions: 

 

Bilateral stimulation of the subthalamic nucleus 
(STN) as an adjunctive therapy to reduce some of 

the symptoms of advanced levodopa-responsive 
Parkinson’s disease that are not adequately 
controlled by medications. 

 

Unilateral or bilateral stimulation of the ventral 

intermediate nucleus (VIM) of the thalamus for 
the suppression of disabling upper extremity 
tremor in adult essential tremor patients whose 
tremor is not adequately controlled by 

medications and where the tremor constitutes a 
significant functional disability. 

Contraindications 

This system is contraindicated for patients who meet 
the following criteria: 

 

Are unable to operate the system 

 

Have unsuccessful test stimulation 

The following procedures are contraindicated for 
patients with a deep brain stimulation system. Advise 
patients to inform their healthcare professional that 

they cannot undergo the following procedures: 

 

Diathermy (short-wave diathermy, microwave 
diathermy, or therapeutic ultrasound diathermy) 

Содержание 3875

Страница 1: ...St Jude Medical Patient Controller For Deep Brain Stimulation Systems Model 3875 User s Guide ...

Страница 2: ...se 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 ...

Страница 3: ...iption 29 About Your System 30 Overview of the Patient Controller 31 Items You Will Receive 34 Your Personal Identification Card 34 Directions for Use 35 Start up Screen 35 Overview of the Therapy Screen 36 Starting and Stopping Stimulation 40 Program Mode 42 Using the Surgery Mode Feature 43 Viewing and Selecting a Program 47 Adjusting Strength 50 System Information 52 Maintaining the Generator a...

Страница 4: ...y Statements 71 Statement of FCC Compliance 71 Statement of Compliance With License Exempt RSS Standard Canada 72 Declaration of Conformity Industry Canada Notice to Users of Radio and Television 73 Identification Information for Product Registration 73 Product Classification Statement CISPR 11 Class B 73 Wireless Technology Information 74 Radio Transmitter Cables Transducers 75 Quality of Service...

Страница 5: ...ns The following symbols may be used in this document and on some of the products and packaging NOTE For symbols and definitions for the patient controller refer to the Apple manual available at http www apple com support ipodtouch or on the patient controller Home screen tap Settings General About Legal Regulatory Apple is a trademark of Apple Inc Table 1 Symbols and definitions Symbol Definition...

Страница 6: ... applied part to protect you from shock The device is internally powered and is intended for continuous operation Device contains a radio frequency RF transmitter which may cause RF interference with other devices near this device Magnetic Resonance MR Unsafe an item poses unacceptable risks to the patient medical staff or other persons within an MR environment Expiration date Date of manufacture ...

Страница 7: ...1 Symbols and definitions Symbol Definition Manufacturing facility Manufacturer Do not use if the product sterilization barrier or its packaging is compromised Contents quantity Batch code Prescription use only ...

Страница 8: ...at this product is disposed of properly you will help prevent potential negative consequences for the environment and human health which could be caused by inappropriate waste handling of this product The recycling of materials will help to conserve natural resources For more information about how to return this product for recycling please contact St Jude Medical Authorized European representativ...

Страница 9: ...Jude Medical declares that this device is in compliance with the essential requirements and other relevant provisions of this directive Australian Communications and Media Authority ACMA and New Zealand Radio Spectrum Management RSM Regulatory Compliance Mark RCM This equipment is certified for type certification pursuant of Article 38 24 of the Japan Radio Law ...

Страница 10: ...A setting that is part of a complete program Prescription and Safety Information Read this section to gather important prescription and safety information Intended Use The St Jude Medical neurostimulation system is designed to deliver electrical stimulation to targets in the brain The St Jude Medical Patient Controller app is intended to be used as part of the system to help the patient manage pre...

Страница 11: ...isabling upper extremity tremor in adult essential tremor patients whose tremor is not adequately controlled by medications and where the tremor constitutes a significant functional disability Contraindications This system is contraindicated for patients who meet the following criteria Are unable to operate the system Have unsuccessful test stimulation The following procedures are contraindicated ...

Страница 12: ...aging MRI Do not perform an MRI on a patient with any implanted neurostimulator or lead or any portion of a lead Even if the neurostimulator has been removed the patient should not have an MRI if any part of a lead or the cranial prosthesis is still implanted The neurostimulation system is MR unsafe Testing has not been performed to define conditions of use to ensure safety of the neurostimulation...

Страница 13: ... and wider pulse widths may indicate a system problem or a suboptimal lead placement Stimulation at high outputs may cause unpleasant sensations or motor disturbances or may render the patient incapable of controlling the patient controller If unpleasant sensations occur the device should be turned off immediately using the patient magnet Risk of depression suicidal ideations and suicide Depressio...

Страница 14: ...or damage your neurostimulation system If you need to receive a procedure using an electrosurgery device place your generator in Surgery Mode Your physician may only use bipolar electrosurgery devices and they should keep the device as far away from your neurostimulation system as possible Additionally they must confirm the neurostimulation system is functioning correctly after your procedure Radi...

Страница 15: ... neurostimulation system is not interfering with the functions of the implanted cardiac system and 3 avoid programming either device in a unipolar mode using the device s can as an anode or using neurostimulation system settings that interfere with the function of the implantable cardiac system Other active implanted devices The neurostimulation system may interfere with the normal operation of an...

Страница 16: ...l probably cause disease symptoms to return In some cases symptoms may return with a greater intensity than what a patient experienced before system implantation rebound effect In rare cases this can create a medical emergency Emergency procedures Designate a representative family member or close friend to notify any emergency medical personnel of your implanted neurostimulation system if emergenc...

Страница 17: ...planted devices Avoid placing equipment components directly over other electronic devices To correct the effect of interference with other devices turn off the equipment or increase the distance between the equipment and the device being affected Application modification To prevent unintended stimulation do not modify the operating system in any way Do not use the application if the operating syst...

Страница 18: ...erfere with the operation of a neurostimulation system or damage system components Avoid getting too close to these types of EMI sources which include the following examples commercial electrical equipment such as arc welders and induction furnaces communication equipment such as microwave transmitters and high power amateur transmitters high voltage power lines radio frequency identification RFID...

Страница 19: ... unauthorized changes to physician established stimulation parameters Damage to shallow implants Falling and other traumatic accidents can damage shallowly implanted components such as the leads and extensions Long term safety and effectiveness The long term safety and effectiveness of this neurostimulation system has not been established beyond 5 years Safety and effectiveness has not been establ...

Страница 20: ...Hospital and Medical Environments Medical tests and procedures Before undergoing medical tests or procedures such as therapeutic radiation or electrolysis contact your physician to determine if the procedure will cause you injury or damage your neurostimulation system Specifically you should be aware that medical devices such as electrohydraulic lithotriptors therapeutic X rays computerized tomogr...

Страница 21: ... an implanted neurostimulation system if used directly over the implanted device External defibrillators Safety for use of external defibrillator discharges on a patient receiving neurostimulation has not been established External defibrillation can cause induced currents in the lead extension portion of the neurostimulation system After defibrillation confirm the neurostimulation system is still ...

Страница 22: ...neurostimulation system to unintentionally turn on or off Patients should also avoid any activities that would be potentially unsafe if their symptoms were to return unexpectedly These activities include but are not limited to climbing ladders and operating potentially dangerous machinery power tools and vehicles Sudden loss of stimulation may cause patients to fall or lose control of equipment or...

Страница 23: ...tion Scuba diving or hyperbaric chambers Patients should not dive below 10 m 33 ft of water or enter hyperbaric chambers above 2 0 atmospheres absolute ATA Pressures below 10 m 33 ft of water or above 2 0 ATA could damage the neurostimulation system Before diving or using a hyperbaric chamber patients should discuss the effects of high pressure with their physician Skydiving skiing or hiking in th...

Страница 24: ...iances that contain magnets e g refrigerators freezers inductive cooktops stereo speakers mobile telephones cordless telephones standard wired telephones AM FM radios and some power tools may unintentionally cause the neurostimulation system to turn on or turn off Therapeutic magnets Patients should be advised to not use therapeutic magnets Therapeutic magnets e g magnets used in pillows mattress ...

Страница 25: ...tion To avoid damage and other potential hazards keep this product away from children and pets Wireless use restrictions In some environments the use of wireless functions e g Bluetooth wireless technology may be restricted Such restrictions may apply aboard airplanes in hospitals near explosives or in hazardous locations If you are unsure of the policy that applies to the use of this device pleas...

Страница 26: ... disposal Device modification This equipment is not serviceable by the customer To prevent injury or damage to the system do not modify the equipment If needed return the equipment to St Jude Medical for service Adverse Effects Deep brain stimulation potentially has the following adverse effects Possible surgical complications Surgical complications include but are not limited to the following int...

Страница 27: ...ed procedures air embolism unable to find target surgical complication etc complications from unusual physiological variations in patients including foreign body rejection phenomena pneumonia seizure or convulsions paralysis loss of motor function inability to move stroke and death Possible deep brain stimulation complications Deep brain stimulation complications include but are not limited to the...

Страница 28: ...odgement Spontaneous turning on or off of the IPG Allergic or rejection response to implanted materials Persistent pain tightness or redness at the incision sites or general pain General erosion or local skin erosion over the IPG Persistent pain tightness or discomfort around the implanted parts e g along the extension path in the neck Impaired wound healing e g incision site drainage or abscess f...

Страница 29: ...ficit headache and hearing and visual disturbance Speech or language impairment including aphasia dysphagia dysarthria and hypophonia Cognitive impairment including attention deficit confusion disorientation abnormal thinking hallucinations amnesia delusions dementia inability to act or make decisions psychic akinesia long term memory impairment psychiatric disturbances depression irritability or ...

Страница 30: ...ce or retention Diarrhea or constipation Cardiac dysfunction e g hypotension heart rate changes or syncope Difficulty breathing Increased salivation Weight gain or loss Eye disorder including eye apraxia or blepharospasm Nausea or vomiting Sweating Fever Hiccups Cough Cramps Worsening existing medical conditions ...

Страница 31: ...ions As with any surgery or therapy deep brain stimulation has risks and complications See the Adverse Effects page 22 for a list of complications associated with deep brain stimulation Most side effects of deep brain stimulation surgery are temporary and are resolved within the first few months However some complications can be more serious or permanent In the event that side effects are intolera...

Страница 32: ...s for you You will likely need to visit your deep brain stimulation team a few times to optimize your settings Some people notice benefits quickly and others may need more time While your clinician is determining your settings you may experience some temporary sensations These temporary sensations normally stop when the settings are changed or adjusted The months following your surgery can be exci...

Страница 33: ... applications on the St Jude Medical Patient Controller Contact St Jude Medical before upgrading the iOS software on your device After upgrading make sure you download the latest St Jude Medical Patient Controller app from the Public App store iOS is a trademark of Cisco Technology Inc NOTE In this document the term patient controller refers to the St Jude Medical Patient Controller device and pat...

Страница 34: ...ect to the leads implanted in the brain The IPG delivers electrical pulses through the extensions and leads to electrodes at a selected target in the brain in order to provide therapeutic stimulation The patient magnet can turn the IPG on and off if the physician enabled this functionality Physicians use the clinician programmer to create and modify a program for a patient Patients use the patient...

Страница 35: ...xtensions 4 Leads 5 Patient magnet Overview of the Patient Controller Refer to the following figure for the patient controller features NOTE For nontherapy related information on how to use the patient controller refer to the Apple manual available at http www apple com support ipodtouch ...

Страница 36: ...32 Figure 2 Patient controller features 1 Power button 2 Patient controller Home button ...

Страница 37: ...ears and then slide the bar to the right To wake the patient controller from sleep mode press the Power button To unlock the patient controller slide the slide to unlock bar to the right To place the patient controller in sleep mode press the Power button Patient controller Home button Press the patient controller Home button to return to the patient controller Home screen To wake the patient cont...

Страница 38: ... up or down Items You Will Receive In addition to the product documentation you will receive the following items to use with your system Patient controller and charging cord Protective case for the patient controller Magnet Your Personal Identification Card A personal medical identification card is included with your product documentation This card does the following things Identifies you as havin...

Страница 39: ...ions Start up Screen Tap the patient controller app icon on the patient controller Home screen to launch the app The patient controller app automatically connects to your generator If you have multiple generators you will need to select the generator from the list NOTE If you need to pair your patient controller and generator see Appendix B Pairing the Patient Controller to the Generator page 70 f...

Страница 40: ...36 Figure 3 Start up screen Overview of the Therapy Screen After the patient controller app connects with the generator the Therapy screen appears ...

Страница 41: ...37 Figure 4 Therapy screen 1 Screen title 2 Generators button 3 Information icon 4 Program name 5 Mode 6 Sleep Timer 7 Therapy button 8 Strength button ...

Страница 42: ...rators button to display the Generator List screen and end the session with the current generator Information icon Tap the Information icon to display the System screen See System Information page 52 for more information Program name Displays the name of the active program Tap to display the Programs screen See Viewing and Selecting a Program page 47 for more information ...

Страница 43: ...d enable Airplane Ready mode or Surgery Mode See Program Mode page 42 for more information Sleep Timer Displays the amount of time until therapy turns off Tap to display the Sleep Timer screen See Program Mode page 42 for more information Therapy button Displays whether therapy is on or off Tap to turn therapy on or off See Adjusting Program Strength for more information ...

Страница 44: ...am Strength for more information Starting and Stopping Stimulation You may start and stop stimulation using the patient controller app or the included magnet if your physician enabled magnet use To start or stop stimulation using the patient controller app perform one of the following Tap the Therapy is ON or Therapy is OFF button on the Therapy screen to turn stimulation on and off NOTE When you ...

Страница 45: ...the magnet perpendicular to and centered directly over the generator site 3 Hold the magnet in place for 2 seconds 4 Remove the magnet replace the keeper bar and store the magnet Stimulation will either start using the most recently used program or stop CAUTION Do not use the magnet provided with the system around magnetically sensitive items to avoid damaging them ...

Страница 46: ...p Timer is off Tap Sleep Timer on the Therapy screen to open the Sleep Timer screen then tap the desired amount of time until stimulation turns off Tap Mode to open the Mode screen From this screen you may place your system in Airplane Ready mode or enable Surgery Mode To enable Airplane Ready mode tap Airplane Ready to view the Airplane Ready screen Follow the instructions on the screen to turn A...

Страница 47: ...t what you need to do before and after a surgical procedure Using this feature turns therapy off while you undergo your procedure NOTE If you feel uncomfortable completing the following steps contact St Jude Medical before your procedure Contact your clinician before your procedure to learn more about any risks ...

Страница 48: ...ng the IPG to Surgery Mode page 44 for instructions Charge your patient controller before the procedure Bring your identification card and patient controller to the procedure Setting the IPG to Surgery Mode To set your IPG into Surgery Mode follow these steps 1 From the Therapy screen tap Mode to display the Mode screen 2 Tap Surgery Mode to view the Surgery Mode screen ...

Страница 49: ...r surgical procedure Disabling the Surgery Mode After your procedure you need to disable Surgery Mode to restart stimulation To disable Surgery Mode follow these steps 1 Launch the patient controller app and connect with your generator You should see the following screen showing that the IPG is in Surgery Mode ...

Страница 50: ...nerator is in Surgery Mode screen 2 Tap Exit Surgery Mode The patient controller app disables Surgery mode The Therapy screen appears showing that stimulation therapy is off 3 To start stimulation tap Therapy is OFF ...

Страница 51: ...s To navigate between the saved programs either Swipe the screen right or left in the area containing the program information Tap the right or left arrows To select a program When you locate the program you want to activate tap Select This Program NOTE When you select a new program stimulation strength will gradually increase to the target strength set for the selected program ...

Страница 52: ...48 Figure 9 Programs screen 1 Cancel button 2 Program name 3 Left arrow 4 Right arrow 5 Program indicator 6 Select This Program button ...

Страница 53: ...he current Programs screen A check mark next to the program name indicates the currently selected program Left and right arrows Tap the left and right arrows to scroll through your saved programs Program indicator Displays the number of programs available and indicates which program is on the screen Select This Program button Tap Select This Program to select the currently displayed program as you...

Страница 54: ...n to open the Strength screen On the Strength screen you can modify strength for the selected side Tap the or buttons to increase or decrease strength The number and green bar above the buttons will increase or decrease as you increase or decrease strength ...

Страница 55: ...51 Figure 10 Strength screen 1 Done button 2 Decrease button 3 Increase button ...

Страница 56: ...cted side Decrease button Tap to decrease the strength for the selected side System Information Tap on the Therapy screen to display the System screen This screen displays the information for your patient controller app and generator such as the generator battery status the patient controller app model number and the software version You can also view information about your generator such as the m...

Страница 57: ...53 Figure 11 System screen ...

Страница 58: ... displayed and when the battery is approaching the end of service is displayed How long the battery lasts depends on the programmed stimulation settings how often stimulation is used and how often you communicate with the generator so communicate with your generator only when necessary NOTE When the generator battery is approaching the end of service a warning pops up on your patient controller ap...

Страница 59: ... the patient controller s battery life so you can anticipate its recharging needs For further information refer to the Apple manual available at http www apple com support ipodtouch Caring for the Patient Controller Clean the protective case for the patient controller by wiping off the outer surface using a moist cloth and a small amount of mild soap Do not use a cloth that is saturated Do not use...

Страница 60: ...rovides troubleshooting procedures to help you identify and solve problems that may occur NOTE If you encounter problems other than those described in this section or if your device is lost or damaged contact Technical Support Table 6 Troubleshooting messages Message Solution Turn On Bluetooth to Access Generator Turn on Bluetooth wireless technology on your patient controller if communication is ...

Страница 61: ...tooth wireless technology toggle button NOTE If you turn Bluetooth wireless technology off and on or reset the app then it will take longer to reconnect to your generator System Problem The system encountered a problem Contact SJM if this problem persists Try the action again If you continue to encounter this problem contact Technical Support ...

Страница 62: ... Generator Battery Status page 54 then try connecting to your generator again If your generator does not have enough battery power contact your physician Generator Not Connected Connect to the generator to adjust your therapy Your connection has timed out Reconnect to your generator Connection Problem with the Generator Try connecting to your generator again If you continue to encounter this probl...

Страница 63: ...ncounter this problem contact Technical Support Connection Not Ready This device was not ready to find the generator Try connecting to your generator again If you continue to encounter this problem contact Technical Support Replace Generator Soon The generator is approaching its end of service and will need to be replaced soon Contact your physician to schedule a replacement Contact your physician...

Страница 64: ...py is OFF Therapy was turned off because the program needed to be reset Tap Dismiss Therapy is OFF You will need to select another program Tap View Programs to select another program Strength was Decreased The generator could not deliver the desired strength Contact your clinician if the problem persists Try adjusting strength again If you continue to encounter this problem contact your physician ...

Страница 65: ...d not deliver the desired strength Contact your clinician if the problem persists Try adjusting strength again If you continue to encounter this problem contact your physician Unsupported Device This application is not compatible with this device Use the device provided by St Jude Medical ...

Страница 66: ...ent controller Home screen to locate app Search for the app using iOS software search functionality Patient controller has no power or has lost power Patient controller s battery is drained Recharge the battery using the charger Patient controller is damaged or malfunctioning Replace the patient controller Patient controller will not charge Charger is disconnected from the patient controller Conne...

Страница 67: ...onnect the appropriate plug adapter voltage converter to the charger Charger is defective Replace the charger Patient controller is damaged or malfunctioning Replace the patient controller Nothing is displayed on the screen Patient controller is off or has timed out Turn on the patient controller Patient controller s battery is drained Recharge the battery using the charger ...

Страница 68: ...solutions for potential issues Problem Possible Cause Possible Solution Screen is damaged or malfunctioning If the patient controller appears to be powered on but without display the screen may be defective Contact Technical Support ...

Страница 69: ...l not respond to input Patient controller has locked up Perform a soft reset 1 Press and hold the Power button until the slide to power off bar appears 2 Slide the bar to the right 3 Press and hold the Power button until the Apple icon appears Touch screen interface is damaged or malfunctioning Replace the patient controller ...

Страница 70: ...or Patient controller is off or has timed out and is in standby mode Wake up the patient controller Patient controller battery is drained Charge the patient controller battery Bluetooth wireless technology connection is not strong or turned off Decrease the distance between the devices Move the devices away from other devices that may be causing interference ...

Страница 71: ...ssible Cause Possible Solution Move the devices so they share line of sight Do not operate other wireless devices at the same time Wait a few minutes and try connecting again Turn Bluetooth wireless technology on using the instructions in the Troubleshooting messages table ...

Страница 72: ...rt for your product use the following information 1 855 478 5833 toll free within North America 1 651 756 5833 For additional assistance call your local St Jude Medical representative Appendix A Downloading the Patient Controller App When you receive your patient controller you need to download the patient controller app so you may use it with your generator The patient controller app is compatibl...

Страница 73: ...en prompts NOTE Use an existing e mail address or set up a free iCloud e mail address Note your password since you will need it to verify your account and update your app iCloud is a trademark of Apple Inc 3 Click Verify now in the e mail sent to your e mail address 4 Follow the onscreen prompts to finish creating your Apple ID To download the app 1 Make sure the device is connected to a Wi Fi net...

Страница 74: ...patient controller to the generator 1 Place the magnet perpendicular to the generator for 10 seconds 2 Tap the patient controller app The patient controller app launches 3 Tap The Add Generator screen opens 4 Tap an available generator in the Select a Generator list If no generators are found you will see the No Generators Found message Tap to search for available generators again and refresh the ...

Страница 75: ...mply with the limits for a Class B digital device pursuant to part 15 of the FCC rules These limits are designed to provide reasonable protection against harmful interference in a residential installation This equipment generates uses and can radiate radiofrequency energy and if not installed and used in accordance with the instructions may cause harmful interference to radio communications Howeve...

Страница 76: ...t cause harmful interference This device must accept any interference received including interference that may cause undesired operation Modifications not expressly approved by the manufacturer could void the user s authority to operate the equipment under FCC rules Statement of Compliance With License Exempt RSS Standard Canada This device complies with Industry Canada license exempt RSS standard...

Страница 77: ...This device has a label that contains among other information a product identifier in the following format Table 8 St Jude Medical Infinity Registration identification information Identifier Type Registration Identifier FCC Registration Number RIASJMRFC Industry Canada IC Registration Number 8454A M3660123 Product Classification Statement CISPR 11 Class B This product is class B equipment which is...

Страница 78: ...logy information Antenna type Embedded patch antenna in header Antenna dimensions 8 1 mm x 5 1 mm x 4 9 mm Modulation GFSK Magnetic field strength at 2 m distance 16 3 µA m Electric field strength at 2 m distance 6 1 mV m Output power EIRP 1 mW 0 dBm typical 10 mW 10 dBm maximum Range 1 2 m typical Center frequency 2 44 GHz Channel 40 logical channels Bandwidth 2 MHz per channel Data flow Bi direc...

Страница 79: ...ers The device contains a radio transmitter receiver with the following parameters Radio transmitter parameters Frequency range 2 4000 to 2 4835 GHz Bandwidth 15dB 2 398 to 2 4855 GHz Channel 40 logical channels using AFH Modulation GFSK Radiated output power 10 mW 10 dBm maximum Magnetic field strength at 2 m distance 16 3 µA m Duty cycle Variable but low 5 Semi duplex capability ...

Страница 80: ...g on the use environment operating room recovery room and home environment After the patient controller is paired with a generator the Bluetooth wireless technology symbol is visible on the patient controller in the upper right hand corner of the screen When the Bluetooth Smart wireless technology connection is not active the symbol appears dimmed The quality of service QoS should allow wireless d...

Страница 81: ...es For information on how to improve connection issues please refer to Troubleshooting for Wireless and Coexistence Issues page 78 Wireless Security Measures The wireless signals are secured through device system design that includes the following The generator will encrypt its wireless communication Only one patient controller may communicate with the generator at the same time A unique key for e...

Страница 82: ...e between the devices Move the devices so they share line of sight Move the devices away from other devices that may be causing interference Close the patient controller application and turn the patient controller off and on Wait a few minutes and try connecting again Do not operate other wireless devices i e laptop tablet mobile phone or cordless phone at the same time NOTE Wireless communication...

Страница 83: ...ined by IEC 60601 1 Edition 3 1 2012 Performance of the device was maintained during immunity testing The device is intended for use in the electromagnetic environment specified in the following tables The user should ensure that it is used in such an environment CAUTION The device complies with the limits for medical devices contained in IEC 60601 1 2 2007 03 IEC 60601 1 2 2014 04 EN 55011 2009 A...

Страница 84: ...nce Electromagnetic Environment Guidance RF emissions CISPR 11 Group 1 The device uses RF energy for its internal and system interface functions Its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment RF emissions CISPR 11 Class B The device is suitable for use in all establishments including domestic establishments and those directly connected to ...

Страница 85: ...t 15 kV air The relative humidity should be at least 5 Electrical fast transient burst IEC 61000 4 4 2 kV for power supply lines 1 kV for input output lines Not applicable No guidance for battery powered devices Surge IEC 61000 4 5 1 kV line to line 2 kV line to earth Not applicable No guidance for battery powered devices Voltage dips short interruptions IEC 61000 4 11 5 UT 40 UT 70 UT Not applica...

Страница 86: ...lds should be at levels characteristic of a typical location in a typical commercial or hospital environment Conducted RF IEC 61000 4 6 6 Vrms 150 kHz to 80 MHz 6 Vrms ISM Radio bands between 150 kHz to 80 MHz 80 AM at 1 kHz 6 Vrms Portable and mobile RF communications equipment should be used no closer to any part of the device including cables than the recommended separation distance calculated ...

Страница 87: ...Recommended separation distance d 0 58 P 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 Radiated RF IEC 61000 4 3 10 V m 80 MHz to 2 7 GHz 80 AM at 1 kHz 20 V m Recommended separation distance d 0 18 P 80 to 800 MHz d 0 35 P 800 MHz to 2 5 GHz ...

Страница 88: ...om 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 NOTE At 80 MHz and 800 MHz the higher frequency range applies NOTE These guidelines may not apply in all situations Electromagnetic propagation is affected by ...

Страница 89: ...plicable RF compliance level above the device should be observed to verify normal operation If abnormal performance is observed additional measures may be necessary such as reorienting or relocating the device b Over the frequency range 150 kHz and 80 MHz field strengths should be less than 3 V m The device is intended for use in the electromagnetic environment in which radiated RF disturbances ar...

Страница 90: ... 61000 4 3 385 MHz 27 V m 18 Hz pulse modulation 27 V m Recommende d separation distance d 0 3 m 450 MHz 28 V m FM modulation 28 V m 710 MHz 745 MHz 780 MHz 9 V m 217 Hz pulse modulation 9 V m 810 MHz 870 MHz 930 MHz 28 V m 18 Hz pulse modulation 28 V m 1720 MHz 1845 MHz 1970 MHz 28 V m 217 Hz pulse modulation 28 V m 2450 MHz 28 V m 217 Hz pulse modulation 28 V m ...

Страница 91: ...e RF communications equipment including peripherals such as antenna cables and external antennas closer than 30 cm 12 inches to any part of the EPG including cables specified by St Jude Medical Otherwise performance degradation may occur NOTE For the frequency bands in the table above use the specified recommended separation distance The recommended separation distances in the table below apply to...

Страница 92: ...munications equipment such as wireless home network devices mobile and cordless telephones and walkie talkies can affect the device Keep the device away from wireless communication equipment at least the distance d as listed in the 800 MHz to 2 5 GHz column in the above table NOTE For transmitters rated at a maximum output power not listed above the recommended separation distance d in meters m ca...

Страница 93: ...w the limits as specified in USA FCC 47 CFR Part 15 2012 Canada RSS 210 Issue 8 Europe ETSI EN 301 489 V1 9 2 ETSI EN 301 489 1 and ETSI EN 301 489 17 NOTE Maintain a reasonable distance between other electronic equipment and the device CAUTION The ISM band used by this device has been approved by the Federal Communications Commission for unlicensed use However there is no guarantee that this devi...

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Страница 96: ...ton Road Plano Texas 75024 USA 1 855 478 5833 1 651 756 5833 St Jude Medical Coordination Center BVBA The Corporate Village Da Vincilaan 11 Box F1 1935 Zaventem Belgium 32 2 774 68 11 sjm com 2017 11 ARTEN600007436 A 600007436 ...

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