Abbott NeuroSphere 3875 User Manual Download

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NeuroSphere™ Patient

Controller

Dorsal Root Ganglion Neurostimulation

Systems

Model 3875

User's Guide

Summary of Contents for NeuroSphere 3875

Page 1: ...NeuroSphere Patient Controller Dorsal Root Ganglion Neurostimulation Systems Model 3875 User s Guide ...

Page 2: ...physician Indicates a trademark of the Abbott group of companies Indicates a third party trademark which is property of its respective owner Bluetooth and Bluetooth logo are registered trademarks of Bluetooth SIG Inc Pat http www abbott com patents 2022 Abbott All Rights Reserved ...

Page 3: ... Patient Controller 25 Items You Will Receive 26 Your Personal Identification Card 27 Directions for Use 28 Connecting to Your Generator 28 Overview of the Therapy Screen 32 Starting and Stopping Stimulation 34 Mode 36 Using the Surgery Mode Feature 38 Using the MRI Mode Feature 40 Viewing and Selecting a Program 45 Adjusting Program Strength 47 System Information 53 Additional Patient Controller ...

Page 4: ...the Patient Controller to the Generator 74 Appendix C Regulatory Statements 76 Statement of FCC Compliance 76 Statement of Compliance With License Exempt RSS Standard Canada 77 Declaration of Conformity Industry Canada Notice to Users of Radio and Television 78 Identification Information for Product Registration 78 Product Classification Statement CISPR 11 Class B 79 Wireless Technology Informatio...

Page 5: ...or product label For harmonized symbols refer to the Universal Symbols Glossary at medical abbott manuals NOTE For symbols and definitions for the patient controller refer to the user guide available at support apple com manuals for the Apple iOS device you are using to run the patient controller app or on the patient controller Home screen tap Settings General Legal Regulatory Table 1 Symbols and...

Page 6: ...in the defined conditions At a minimum address the conditions of the static magnetic field the switched gradient magnetic field and the radiofrequency fields Additional conditions including specific configurations of the item may be required MR Unsafe NOTE Magnetic Resonance MR Unsafe an item poses unacceptable risks to the patient medical staff or other persons within an MR environment Non ionizi...

Page 7: ...from the intrusion of solid foreign objects as small as 12 5 mm in diameter and is protected from vertically dripping water when the device is tilted at an angle up to 15 degrees Use by date Date of manufacture Catalog number NOTE This symbol also refers to the model number Manufacturing facility Temperature limit Humidity limitation 3 ...

Page 8: ...o not use if package is damaged Packaging unit Programmer Accessories Serial number Batch code Unique Device Identification Prescription use only This product shall not be treated as household waste Instead it is the user s responsibility to return this product to Abbott Medical for reprocessing 4 ...

Page 9: ...rces For more information about how to return this product for recycling please contact Abbott Medical Authorized representative in the European Community European conformity affixed in accordance with the relevant provisions of AIMD directive 90 385 EEC Hereby Abbott Medical declares that this device is in compliance with the essential requirements and other relevant provisions of this directive ...

Page 10: ...implanted parts that allows a patient to receive a magnetic resonance imaging MRI scan safely if all the requirements for the implanted parts and for scanning are met Program A combination of one or more subprograms areas Prescription and Safety Information Read this section to gather important prescription and safety information Intended Use This neurostimulation system is designed to deliver low...

Page 11: ... prior pharmacologic treatments from at least two different drug classes and continued their pharmacologic therapy during the clinical study Please note that in 1994 a consensus group of pain medicine experts gathered by the International Association for the Study of Pain IASP reviewed diagnostic criteria and agreed to rename reflex sympathetic dystrophy RSD and causalgia as complex regional pain ...

Page 12: ... cause a jolting or shocking sensation If you are using a permanent system you may be implanted with the parts that make up a Magnetic Resonance MR Conditional system which allows you to receive an MRI scan if all the requirements for the implanted parts and for scanning are met Scanning under different conditions may cause device malfunction severe injury or death Contact your physician before re...

Page 13: ...or the Apple iOS device you are using to run the patient controller app System Warnings Pregnancy and nursing Safety and effectiveness of neurostimulation for use during pregnancy nursing the unborn fetus or delivery have not been established Pediatric use Safety and effectiveness of neurostimulation for pediatric use have not been established Back pain The safety and efficacy for the treatment of...

Page 14: ...art of a neurostimulation system implanted Energy from diathermy can be transferred through the implanted system and can cause tissue damage at the location of the implanted electrodes resulting in severe injury or death Diathermy is further prohibited because it may also damage the neurostimulation system components This damage could result in loss of therapy requiring additional surgery for syst...

Page 15: ...ulation system 1 maximize the distance between the implanted systems 2 verify that the 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 functions of the implantable cardiac system Other active impl...

Page 16: ...he system may not be immediately detectable Component manipulation Do not rub or press on implanted components through the skin This may cause the leads to move leading to stimulation at the implant site IPG inversion leading to the inability to communicate with the device or skin erosion that can lead to another surgical procedure or possible infection Implantation at vertebral levels above T10 T...

Page 17: ...l System Routine medical procedures If you are using a trial system inform your healthcare providers and avoid elective medical procedures Additional Warnings Only Applicable to the Permanent System 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 le...

Page 18: ...not use an EPG or patient controller in an environment where explosive or flammable gas fumes or vapors are present including hyperbaric chambers Operating these devices could cause them to ignite causing severe burns injury or death Interference with other devices This equipment can radiate radiofrequency RF energy that may interfere with other electronic devices Avoid placing equipment component...

Page 19: ...out of the reach of children Precautions The following precautions apply to these components NOTE For nontherapy related precautions for the NeuroSphere Patient Controller refer to the user guide available at support apple com manuals for the Apple iOS device you are using to run the patient controller app System Precautions Physician instructions Always follow the programs and therapy instruction...

Page 20: ...he stimulation strength before stretching lifting your arms over your head or exercising If unpleasant sensations occur turn off stimulation Stimulation effectiveness The long term effectiveness of dorsal root ganglion DRG stimulation has not been documented and not all patients realize the long term benefits from DRG stimulation Stimulation effectiveness has been established for one year Electrom...

Page 21: ...ical interference keep wireless communication equipment at least 15 cm 6 in from the generator Wireless use restrictions In some environments the use of wireless functions for example Bluetooth wireless technology may be restricted Such restrictions may apply aboard airplanes near explosives or in hazardous locations If you are unsure of the policy that applies to the use of this device please ask...

Page 22: ...uickly Magnet usage The magnet provided with the system is a high powered magnet intended for use solely with the system Keep it away from watches credit cards computer disks and other magnetically sensitive items to avoid damaging them Always place the keeper bar on the magnet when not in use Home use This product is intended for home use per physician instruction To avoid damage and other potent...

Page 23: ...sician to discuss modifying the magnet mode setting on your neurostimulation system or if you have any other questions Additional Precautions Only Applicable to the Trial System Battery damage If the internal batteries are shorted it is possible for the external temperature of the pouch to reach 42 C 107 F which could damage the EPG If this occurs contact your clinician Additional Precautions Only...

Page 24: ...with the IPG Use your patient controller to communicate with your IPG only when needed because excessive communication with the IPG can shorten the remaining battery life Device Precautions Handle the device with care The device is a sensitive electronic device that can be damaged by rough handling such as dropping it on the ground Battery precaution This device contains a lithium ion battery as w...

Page 25: ...s in tissue around the electrodes changes in electrode position loose electrical connections or lead failure or breakage Stimulation in unwanted places such as stimulation of the chest wall Lead migration causing changes in stimulation or reduced pain relief Epidural hemorrhage hematoma infection spinal cord compression or paralysis from placement of a lead in the epidural space Cerebrospinal flui...

Page 26: ...pression and paralysis and requires surgical intervention Time to onset can range from weeks to many years after implant Additional risks as a result of the placement and stimulation of the lead in the area of the dorsal root ganglion DRG include pain from setting the stimulation parameters too high This may occur once the lead is in place and is connected to the neurostimulator and activated The ...

Page 27: ...to the NeuroSphere Patient Controller application app About Your System This neurostimulation system is designed to deliver low intensity electrical impulses to nerve structures The neurostimulation system includes the following primary components External pulse generator EPG or Implantable pulse generator IPG Extensions Leads Patient magnet provided by Abbott Medical Patient controller a device p...

Page 28: ...he patient magnet can turn the EPG or 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 controller to control their prescribed program The following image shows how the major system components are intended to interact 24 ...

Page 29: ...e Patient Controller Your patient controller may be a device provided by Abbott Medical or a compatible personal Apple iOS device Before you begin be sure you are familiar with how to perform basic operational functions on your patient controller Turning the patient controller on and off Placing the patient controller in sleep mode 25 ...

Page 30: ...tient controller app The patient controller app is available from the Apple App Store and can be downloaded to your device using your Apple ID See Appendix A Downloading the Patient Controller App page 73 for more information on compatible devices and for instructions on downloading the patient controller app Items You Will Receive If you are using a patient controller provided by Abbott Medical y...

Page 31: ...your physician submit a patient registration form Abbott Medical will mail you a permanent identification card The registration card does the following things Identifies you as having an implanted medical device Identifies the model numbers and locations of your implanted system parts to help determine if you can safely receive an MRI scan Helps you pass through security systems like those in airp...

Page 32: ...ou turn on your patient controller the patient controller app should be available on the Home screen If you do not see the patient controller app see Appendix A Downloading the Patient Controller App page 73 for instructions Figure 2 Patient controller app icon 1 Tap the patient controller app icon The Start up 1 screen appears 28 ...

Page 33: ...vacy Policy screens will display requiring your agreement before you can use the app 2 Tap Accept on the Terms of Use screen 2 3 Tap Acknowledge on the Privacy Policy screen 3 NOTE To view this information again tap the Information icon and then Terms of Use or Privacy Policy on the Information screen After your app launches the Generators screen appears 29 ...

Page 34: ...lays see Appendix B Pairing the Patient Controller to the Generator page 74 for instructions 4 Select your generator If you have multiple 4 generators select the generator you want to use from the list After selecting your generator the patient controller app connects with the generator NOTE After 3 minutes of inactivity the patient controller app will disconnect from your generator 30 ...

Page 35: ...erruption while adjusting your therapy Abbott Medical recommends enabling Do Not Disturb mode on your patient controller before connecting to your generator Refer to the user guide available at support apple com manuals for the Apple iOS device you are using to run the patient controller app If a passcode is not set for the device the Consider adding a passcode to this device message will display ...

Page 36: ...roller app connects with the generator the Therapy screen appears Figure 5 Therapy screen 1 Screen title 1 2 Back button 2 3 Information icon 3 4 Program name 4 5 Mode 5 6 Sleep Timer 6 7 Therapy button 7 8 Stimulation map 8 9 Adjust Strength button 9 32 ...

Page 37: ...on screen See System Information page 53 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 45 for more information Mode Displays the active dosage Continuous Intermittent or Sleep Tap to display the Mode screen and enable Airplane Ready mode Surgery Mode or MRI Mode See Mode page 36 for more informa...

Page 38: ...splay the Strength screen See Adjusting Program Strength page 47 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 has enabled magnet use Starting and Stopping Stimulation Using the Patient Controller To start or stop stimulation using the patient controller app do one of the following...

Page 39: ... the last used strength level Starting and Stopping Stimulation Using the Magnet If your physician has enabled magnet use you may start and stop stimulation with a magnet To start or stop stimulation using the magnet 1 Take the keeper bar off the magnet 1 Figure 6 Magnet and keeper bar 1 Magnet 1 2 Keeper bar 2 2 Hold the magnet perpendicular to and centered 2 directly over the generator site 3 Ho...

Page 40: ...tion on and off for the preset periods in the selected program displays the remaining time in the current on or off period Sleep stimulation is on for a programmed amount of time after which stimulation turns off and stays off until it is manually turned on trial system only The Sleep Timer which is only available with the permanent system displays the remaining stimulation time or Off if the Slee...

Page 41: ...llow the instructions on the screen to turn Airplane Ready on or off For instructions about turning Bluetooth wireless technology on see Troubleshooting page 63 For more information about Surgery Mode see Using the Surgery Mode Feature page 38 For more information about MRI Mode see Using the MRI Mode Feature page 40 Figure 7 Mode screen 37 ...

Page 42: ...edure to learn more about any risks Preparing for a Surgical Procedure If you are going to undergo a surgical procedure follow these guidelines Set your IPG to Surgery Mode before your procedure See Setting the IPG to Surgery Mode page 38 for instructions Charge your patient controller before the procedure Bring your identification card and patient controller to the procedure Setting the IPG to Su...

Page 43: ...rgo your surgical procedure Disabling the Surgery Mode After your procedure you need to disable Surgery Mode to restart stimulation To disable Surgery Mode 1 Launch the patient controller app and connect with 1 your generator You should see the following screen showing that the IPG is in Surgery Mode 39 ...

Page 44: ...off 3 To start stimulation tap Therapy is OFF 3 Using the MRI Mode Feature You may be implanted with the parts that make up a Magnetic Resonance MR Conditional system which allows you to receive an MRI scan if all the requirements for the implanted parts and scanning are met This section provides information and instructions about what you need to do before and after an MRI scan 40 ...

Page 45: ... screen displays the message System is MR Conditional if implanted parts of your system are approved MR Conditional models Tap Mode on the Therapy screen to display the Mode screen The MRI Mode option is available if implanted parts of your system are approved MR Conditional models Preparing for an MRI Scan If you have an MR Conditional system and will receive an MRI scan follow these guidelines S...

Page 46: ... into the scanner magnet room since it may be affected by the MRI magnet may present a projectile hazard and is MR Unsafe Setting the IPG to MRI Mode To set your IPG into MRI mode 1 From the Therapy screen tap Mode to display the 1 Mode screen 2 Tap MRI Mode to view the MRI Mode screen 2 Figure 10 MRI Mode screen 42 ...

Page 47: ...Troubleshooting page 63 for more information 5 Tap OK 5 CAUTION Do not delete the paired Bluetooth wireless connection between the IPG and the patient controller and do not delete the IPG from the Generators list while the system is in MRI mode Doing so will prevent the system from disabling MRI mode which may prevent therapy from being turned on again Disabling the MRI Mode After your procedure y...

Page 48: ...gure 11 MRI Mode screen 2 Tap Exit MRI Mode The patient controller app 2 disables MRI mode The Therapy screen appears showing that stimulation therapy is off 3 To start stimulation tap Therapy is OFF 3 44 ...

Page 49: ...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 last used strength level if applicable Otherwise stimulation strength will gradually increase to the strength level set for the selected program When using a trial system stimulat...

Page 50: ...Figure 12 Programs screen 1 Cancel button 1 2 Program name 2 3 Left arrow 3 4 Right arrow 4 5 Program indicator 5 6 Select This Program button 6 46 ...

Page 51: ...rogram 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 your active program Adjusting Program Strength Tap Adjust Strength on the Therapy screen to open the S...

Page 52: ...ed area in dark blue 2 Tap the or buttons to increase or decrease 2 strength for the selected area The green bar below the area name will increase or decrease as you increase or decrease strength You will see the Adjusting Strength message while the system is adjusting 3 Modify other areas as needed by following the steps 3 above 4 When you are finished adjusting the area strength 4 tap Done to re...

Page 53: ...Figure 13 Strength screen Independent tab 1 Done button 1 2 Independent tab 2 3 Grouped tab 3 4 Selected Area 4 5 On or Off switch 5 6 Stimulation map 6 7 Increase button 7 8 Decrease button 8 49 ...

Page 54: ... strength for all areas 3 The green bars below the area name will increase or 3 decrease as you increase or decrease strength 4 You will see the Adjusting Strength message while 4 the system is adjusting 5 When you are finished adjusting the Area strength 5 tap Done to return to the Therapy screen 50 ...

Page 55: ...Figure 14 Strength screen Grouped tab 1 Done button 1 2 Independent tab 2 3 Grouped tab 3 4 On or Off switch 4 5 Stimulation map 5 6 Increase button 6 7 Decrease button 7 51 ...

Page 56: ...If you only have one area you will see the following screen Figure 15 Strength screen One Area 52 ...

Page 57: ... only have one area you will not see the Grouped tab On or Off switch Tap to turn stimulation for the selected area on or off Increase button Tap to increase the strength for the corresponding area Decrease button Tap to decrease the strength for the corresponding area System Information Tap on the Therapy screen to display the system information From these screens you can view the information for...

Page 58: ...Figure 16 System information Generator screen 1 Done button 1 2 Manuals button 2 3 Generator button 3 4 Leads Extensions button 4 5 Patient Controller button 5 54 ...

Page 59: ...Tap to view information about your leads and extensions such as the model numbers Patient Controller button Tap to view information about your patient controller such as the patient controller app model number Additional Patient Controller Information Tap at the bottom of the Generators screen to view additional patient controller information view the Instructions for Use IFU and export the patien...

Page 60: ... 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 You may also receive low battery warnings regarding the patient controller so make sure to read the warning before dismissing To view the IPG battery status The generator battery indicator on the Gen...

Page 61: ...ttery indicator progression NOTE When using a trial system contact your physician for replacement batteries if your battery indicator shows 2 or less as shown in the figure below Do not attempt to replace the batteries Figure 17 EPG battery indicator progression NOTE When the remaining EPG battery charge reaches 2 or 1 a warning pops up on your patient controller app When the EPG battery is too lo...

Page 62: ...personal information may be transferred to the patient controller which will be returned to Abbott Medical NOTE Keep the patient controller charged or have a power supply nearby Familiarize yourself with the patient controller s battery life so you can anticipate its recharging needs For more information refer to the user guide available at support apple com manuals for the Apple iOS device you ar...

Page 63: ... not use alcohol ammonia based cleaning agents cleaning solutions or solvents to clean the case NOTE For more information on how to care for the patient controller refer to the user guide available at support apple com manuals for the Apple iOS device you are using to run the patient controller app Cybersecurity To protect the devices products and systems that connect patients to healthcare profes...

Page 64: ...se manual by product section tap the Apple device you are using to run the patient controller app and then scroll and tap the User Guide for your device s iOS version 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...

Page 65: ...em is compromised for example jailbroken Do not share your Apple ID login information or device passcode Do not leave the device unattended where it could be lost or stolen Do not allow other users to access the mobile device unless you also give them permission to access the patient controller app which lets them control your therapy Do not install untrusted apps on the device you are using to ru...

Page 66: ...lable by Apple after verifying iOS software version compatibility with the Patient Controller App via www NMmobiledevicesync com cp Legal and Privacy Notice The terms of use and privacy policy are displayed the first time the patient controller app is launched after installing or updating the app To view this information again tap on the Generators screen or view online at https www virtualclinic ...

Page 67: ...cal neurostimulation system components as stated in the Limited Warranty card included in your product documentation Table 6 Possible causes and solutions for potential issues Problem Possible Cause Possible Solution Patient Controller App Cannot locate patient controller app Patient controller app is not on patient controller Home screen Swipe through screens from the patient controller Home scre...

Page 68: ...act Technical Support Patient Controller Device Patient Controller is not accessible Patient controller is lost or damaged Contact Technical Support If you receive a replacement patient controller see Appendix B Pairing the Patient Controller to the Generator page 74 Patient controller has no power or has lost power Patient controller s battery is drained Charge the patient controller Patient cont...

Page 69: ...thing is displayed on the screen Patient controller is off or is in Sleep mode Turn on the patient controller Patient controller s battery is drained Charge the patient controller 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 Patient controller will not respond to input Patient contro...

Page 70: ...et perpendicular to and centered directly over the generator site See Starting and Stopping Stimulation Using the Magnet page 35 Patient controller battery is drained Charge the patient controller battery Bluetooth wireless 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 Move the devices so t...

Page 71: ... device provided by Abbott Medical or a compatible personal Apple iOS device NOTE For more information on compatible devices see Appendix A Downloading the Patient Controller App page 73 Generator Generator Unavailable message appears The generator is not in range Decrease the distance between the generator and patient controller Low Generator Battery message appears The EPG battery needs to be re...

Page 72: ... No stimulation Stimulation is off possibly due to a generator reset or magnet application Turn on stimulation using the patient controller app or magnet if enabled Stimulation turns off unexpectedly The system impedance is measuring impedance and has stopped stimulation temporarily Stimulation will resume when the impedance measurement is completed A magnet was used to turn off stimulation Turn o...

Page 73: ...n or Connection Patient controller cannot establish Bluetooth wireless connection with the generator or the connection was lost Interference in the environment for example from microwave ovens and Wi Fi routers Move to a different area or room away from the interference Patient controller is off or has timed out and is in standby mode Wake up the patient controller Patient controller battery is dr...

Page 74: ...e patient controller is in Bluetooth wireless range of the generator within 3 ft or 0 9 m Turn on Bluetooth wireless technology on your patient controller if communication is disabled 1 Return to the patient 1 controller Home screen and tap Settings 2 Tap Bluetooth then 2 tap the Bluetooth toggle button NOTE If you turn Bluetooth wireless technology off and on or reset the app it will take longer ...

Page 75: ...ia accessories such as headphones or speakers AirPlay AirDrop CarPlay or Hotspot Surgery Mode Cannot put the generator in Surgery mode The generator is not connected to the patient controller Try connecting to the generator again If the problem persists contact Technical Support The generator is in MRI mode Exit MRI mode to set Surgery mode MRI Mode MRI is Not Permitted is displayed instead of the...

Page 76: ...an may be able to perform an additional check to see if MRI Mode can be set Cannot put the generator in MRI mode The generator is not connected to the patient controller Try connecting to the generator again If the problem persists contact Technical Support The generator is in Surgery mode Exit Surgery mode to set MRI mode Technical Support For technical questions and support for your product use ...

Page 77: ...is running an Apple released iOS version before downloading the patient controller app If you do not have an Apple ID you can create one while setting up the device or before installing the app For instructions refer to the Apple ID support page at support apple com Tap the drop down menu or scroll down to locate the Search Support box Tap in the Search Support box type Apple ID and then select th...

Page 78: ...ed to a 1 Wi Fi network 2 Tap the App Store icon on the patient controller 2 Home screen 3 Enter Abbott Patient Controller in the Search field 3 4 Once you locate the correct app follow the 4 onscreen prompts NOTE If you encounter problems downloading the app contact Technical Support Appendix B Pairing the Patient Controller to the Generator To pair the patient controller to the generator 1 Place...

Page 79: ...lable generator in the Select a 4 Generator list If the No Generators Found message displays repeat step 1 and then tap to search for available generators again and refresh the generator list 5 Enter the pin code displayed on the screen in the 5 Bluetooth Pairing Request dialog box 75 ...

Page 80: ...y Statement of FCC Compliance This equipment has been tested and found to comply 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 th...

Page 81: ...to the following two conditions This device may not 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 complie...

Page 82: ...uirements of the Canadian interference causing equipment regulations Identification Information for Product Registration This device has a label that contains among other information a product identifier in the following format Table 7 EPG Registration identification information Identifier Type Registration Identifier FCC Registration Number PX2SJMX599EPG Industry Canada IC Registration Number 845...

Page 83: ...lass B This product is class B equipment which is intended primarily for use in the domestic environment Wireless Technology Information The following table summarizes the technical details of the Bluetooth Low Energy LE wireless technology as it is implemented in the device Table 9 Bluetooth Low Energy LE wireless technology information EPG Antenna type Embedded ceramic antenna IPG Antenna type E...

Page 84: ...agnetic Field Strength at 10 m distance 0 000145 A m maximum IPG Magnetic Field Strength at 2 m distance 16 3 µA m EPG Electric Field Strength 0 055 V m maximum IPG Electric Field Strength at 2 m distance 6 1 mV m Output power EIRP 1 mW 0 dBm typical 10 mW 10 dBm maximum EPG Range 2 meters typical IPG Range 1 2 m typical Center frequency 2 44 GHz Channel 40 logical channels 80 ...

Page 85: ...ransmitter Cables Transducers The device contains a radio transmitter receiver with the following parameters Radio transmitter parameters Frequency range 2 4000 to 2 4835 GHz Bandwidth 15 dB 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 ...

Page 86: ...rating 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 wireless connection is not active the symbol is grayed out The standard Bluetooth LE wireless technology data rate is 1 Mbit s The quality of service QoS s...

Page 87: ...decrease the distance between connected devices For information on how to improve connection issues see Troubleshooting for Wireless and Coexistence Issues page 83 Troubleshooting for Wireless and Coexistence Issues If you experience issues with the wireless communication between the generator and the patient controller try the following Decrease the distance between the devices Move the devices s...

Page 88: ... accordance with the information provided in this manual The device was tested for basic safety and essential performance as defined by IEC 60601 1 AMD1 2012 Edition 3 1 Performance of the device was maintained during electromagnetic disturbance 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...

Page 89: ...omagnetic Environment Guidance RF emissions CISPR 11 Group 1 The device produces RF emissions as a result of 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 conne...

Page 90: ...le No guidance for battery powered devices Surge IEC 61000 4 5 1 kV line to line 2 kV line to ground Not applicable No guidance for battery powered devices Voltage dips short interruptions IEC 61000 4 11 5 UT 40 UT 70 UT Not applicable No guidance for battery powered devices Power frequency 50 60 Hz magnetic field IEC 61000 4 8 30 A m 30 A m Power frequency magnetic fields should be at levels char...

Page 91: ...ances are controlled The customer or the user of the device can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment transmitters and the device as recommended below according to the maximum output power of the communications equipment Recommended minimum separation distance for higher immunity test levels Radiated RF I...

Page 92: ... is the maximum power in watts W d is the recommended separation distance in meters m and E is the immunity test level in volts per meter V m NOTE UT is the AC mains voltage prior to application of the test level NOTE These guidelines may not apply in all situations Electromagnetic propagation is affected by absorption and reflection from structures objects and people 88 ...

Page 93: ...4 3 385 MHz 27 V m 18 Hz pulse modulation 27 V m Recommended minimum 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 89 ...

Page 94: ... V m WARNING Do not use portable RF communications equipment including peripherals such as antenna cables and external antennas closer than 30 cm 12 inches to any part of the device including cables specified by Abbott Medical Otherwise performance degradation may occur Radio Frequency Information The effective radiated power is below the limits as specified in USA FCC 47 CFR Part 15 2012 Canada R...

Page 95: ...er 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 device will not receive interference or that any particular transmission from this device will be free from interference 91 ...

Page 96: ...www abbott com 2022 08 ARTEN600266402 A 600266402 ...

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