Abbott NeuroSphere 3875 User Manual

Patient controller

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NeuroSphere™ Patient

Controller

Dorsal Root Ganglion Neurostimulation

Systems

Model 3875

User's Guide

Table of Contents

Summary of Contents for Abbott NeuroSphere 3875

Page 1 NeuroSphere™ Patient Controller Dorsal Root Ganglion Neurostimulation Systems Model 3875 User's Guide...
Page 2 CAUTION: Federal (USA) law restricts this device to sale by or on the order of a 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.
Page 3: Table Of Contents
Contents About This Guide........1 Symbols and Definitions.
Page 4 Checking the Patient Controller Battery Status..... . . 58 Caring for the Generator......... 58 Caring for the Patient Controller.
Page 5: About This Guide
The symbols below and harmonized symbols may be found on the product 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‡...
Page 6 Table 1. Symbols and definitions Symbol Definition Follow instructions for use on this website Type BF Applied Part MR Conditional NOTE: Magnetic Resonance (MR) Conditional, an item with demonstrated safety in the MR environment within the defined conditions. At a minimum, address the conditions of the static magnetic field, the switched gradient magnetic field, and the radiofrequency fields.
Page 7 Table 1. Symbols and definitions Symbol Definition Keep dry; keep away from rain Ingress protection rating for a device that is protected 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...
Page 8 Do 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.
Page 9 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. Australian Communications and Media...
Page 10: Terms Used In This Document
Table 1. Symbols and definitions Symbol Definition This equipment is certified for type certification pursuant of Article 38‑24 of the Japan Radio Law Terms Used in This Document This section contains definitions of some of the terms used in this document. Magnetic Resonance (MR) Conditional system.
Page 11: Indications For Use
used with the generator to help the patient manage prescribed stimulation programs. Indications for Use This neurostimulation system is indicated for spinal column stimulation via epidural and intraspinal lead access to the dorsal root ganglion as an aid in the management of moderate to severe chronic intractable* pain of the lower limbs in adult patients with complex regional pain syndrome (CRPS) types I and II.**...
Page 12: Contraindications
Contraindications This neurostimulation system is contraindicated for patients who are ▪ ▪ Unable to operate the system ▪ ▪ Poor surgical risks Patients who failed to receive effective pain relief during trial stimulation are contraindicated to proceed to the permanent implant procedure. MRI Safety Information If you are using a trial system, you should not be subjected to an MRI.
Page 13: Warnings
Do not bring your patient controller into the scanner magnet room. It can be affected by the MRI magnet, may present a projectile hazard, and is MR Unsafe. For more information about what you need to do to prepare for an MRI scan, refer to “Using the MRI Mode Feature”...
Page 14 damage your neurostimulation system. Specifically, you should be aware that medical devices such as electrohydraulic lithotriptors, therapeutic X‑rays, computerized tomography (CT) scans, cobalt machines, and linear accelerators may cause damage to the electronic circuitry of an implanted neurostimulation system. If using a trial system and radiation therapy is required, disconnect the trial generator from the leads or extensions.
Page 15 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. Implanted cardiac system. Be aware of the risk and possible interaction between a neurostimulation system and an implanted cardiac system, such as a pacemaker or defibrillator.
Page 16 medical personnel of your implanted system. Use caution when undergoing any procedure that could include radiofrequency (RF) or microwave ablation, defibrillation, or cardioversion. Therapeutic radiation. Therapeutic radiation may damage the electronic circuitry of a neurostimulation system, although no testing has been done and no definite information on radiation effects is available.
Page 17 overstimulation. Excessive lead migration may require reoperation to replace the leads. Operation of machines, equipment, and vehicles. If you feel uncomfortable paresthesia during postural changes do not operate potentially dangerous equipment such as power tools, automobiles, or other motor vehicles. Do not climb ladders or participate in activities where postural changes or abrupt movements could cause overstimulation (jolting sensation) and cause you to fall...
Page 18 Device modification. The 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 Abbott Medical for service.
Page 19: Precautions
Keep the device dry. Your EPG and patient controller devices are not waterproof. Keep them dry to avoid damage. Do not use your device when engaging in activities that might cause it to get wet, such as swimming or bathing. Application modification.
Page 20 Device components. The use of components not approved for use by Abbott Medical may result in damage to the system and increased risk of injury. Infection. Follow proper infection control procedures and avoid showering and touching the bandages. High stimulation outputs.
Page 21 communication equipment (such as microwave transmitters and high-power amateur transmitters), high-voltage power lines, radiofrequency identification (RFID) devices, some medical procedures (such as therapeutic radiation, static magnetic field [SMF] therapy, and electromagnetic lithotripsy), and some medical devices (such as bone growth stimulators, transcutaneous electrical nerve stimulation [TENS] devices, dental drills, and ultrasonic probes).
Page 22 stores and loan desks at libraries, may also affect stimulation. Note that these devices may also be concealed in doorways. Patients who are implanted with nonadjacent multiple leads and patients who are sensitive to low stimulation thresholds may experience a momentary increase in their perceived stimulation, which some patients have described as uncomfortable or jolting.
Page 23 Consumer goods and electronic devices. Magnetic interference with consumer goods or electronic devices that contain magnets, such as mobile phones and smart watches, may unintentionally cause the neurostimulation system to turn on or turn off or affect communication between the patient controller and generator;...
Page 24 This device contains a lithium ion battery as well as other potentially hazardous materials. Do not crush, puncture, or burn the device because explosion or fire may result. Return it to Abbott Medical for proper disposal. Control of your device.
Page 25: Adverse Effects
Adverse Effects The use of a neurostimulation system involves risks. In addition to those risks commonly associated with surgery, the following risks are also associated with use of a neurostimulation system: ▪ ▪ Unpleasant sensations or motor disturbances, including involuntary movement, caused by stimulation at high outputs (if either occurs, turn off stimulation immediately) ▪...
Page 26 ▪ ▪ Seroma (mass or swelling) at the implant site ▪ ▪ Headache ▪ ▪ Allergic or rejection response to device or implant materials ▪ ▪ Implant migration or skin erosion around the implant ▪ ▪ Battery failure, leakage, or both ▪...
Page 27: Product Description
▪ Extensions ▪ ▪ Leads ▪ ▪ Patient magnet (provided by Abbott Medical) ▪ ▪ Patient controller (a 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...
Page 28 The EPG or IPG delivers electrical pulses through the leads to electrodes near selected nerve fibers to provide therapeutic stimulation. The 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.
Page 29: Overview Of The Patient Controller
4. Patient magnet Overview of the 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: ▪...
Page 30: Items You Will Receive
Items You Will Receive If you are using a patient controller provided by Abbott Medical, you will receive the following items to use with your system: ▪ ▪ Patient controller and charging cord ▪...
Page 31: Your Personal Identification Card
Your physician will complete the card and give it to you. Once you or your physician submit a patient registration form, Abbott Medical will mail you a permanent identification card. The registration card does the following things: ▪...
Page 32: Directions For Use
Directions for Use Read this section for instructions on how to use the patient controller app. Connecting to Your Generator When you 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 33 Figure 3. Start-up screen If you have not previously launched the patient controller app after installation or update and accepted the Terms of Use and the Privacy Policy, screens will display requiring your agreement before you can use the app. 2.
Page 34 Figure 4. Generators screen* * The generator icon in this screen is a representation. The actual screen displays an icon of the implanted generator. NOTE: If the “No Generators Found” message displays, see “Appendix B: Pairing the Patient Controller to the Generator”...
Page 35 ▪ To avoid interruption 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‡...
Page 36: Overview Of The Therapy Screen
Overview of the Therapy Screen After the patient controller app connects with the generator, the Therapy screen appears. Figure 5. Therapy screen 1. Screen title 2. Back button 3. Information icon 4. Program name 5. Mode 6. Sleep Timer 7. Therapy button 8.
Page 37 Table 2. Therapy screen descriptions Screen Section Description or Button Name Screen title Displays the name of the screen you are viewing. Back button Tap to display the Generators screen and end the session with the current generator. Information icon Tap the Information icon to display the system information screen.
Page 38: Starting And Stopping Stimulation
Table 2. Therapy screen descriptions Screen Section Description or Button Name See “Mode” (page 36) for more information. Therapy button Displays whether therapy is on or off. Tap to turn therapy on or off. Stimulation map Displays the body area currently receiving stimulation.
Page 39 ▪ ▪ Adjust stimulation strength all the way down on the Grouped Strength screen. See “Adjusting Program Strength” (page 47) for more information. NOTE: When you turn stimulation on from the Therapy screen, stimulation strength will gradually return to the last used strength level. Starting and Stopping Stimulation Using the Magnet If your physician has enabled magnet use, you may start...
Page 40: Mode
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. Mode Depending on the programmed dosage, Continuous, Intermittent, or Sleep is displayed on the Therapy...
Page 41 enable Surgery Mode, or enable MRI Mode (when applicable). ▪ ▪ To enable Airplane Ready mode, tap Airplane Ready to view the Airplane Ready screen. Follow the instructions on the screen to turn Airplane Ready on or off. For instructions about turning Bluetooth® wireless technology on, see “Troubleshooting”...
Page 42: Using The Surgery Mode Feature
Using this feature turns therapy off while you undergo your procedure. NOTE: If you feel uncomfortable completing the following steps, contact Abbott Medical before your procedure. Contact your clinician before your procedure to learn more about any risks. Preparing for a Surgical Procedure...
Page 43 Figure 8. Surgery Mode screen 3. Tap the Surgery Mode toggle button. Stimulation stops and you may undergo your surgical procedure. Disabling the Surgery Mode After your procedure, you need to disable Surgery Mode to restart stimulation. To disable Surgery Mode: 1.
Page 44: Using The Mri Mode Feature
Figure 9. Generator 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. 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...
Page 45 NOTE: Contact your clinician before receiving an MRI scan to find out if you can undergo the procedure and to learn more about any risks. You have two ways to learn if the implanted parts of your system are MR Conditional: ▪...
Page 46 ▪ ▪ Bring your identification card and patient controller to the procedure. CAUTION: Do not bring your patient controller 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.
Page 47 3. Tap the MRI Mode toggle button. 4. When the “Set Generator to MRI Mode” message appears, tap Continue. Stimulation stops, and the patient controller app checks the system for any issues. If the checks are successful, the “Proceed with MRI” message appears and the MRI mode is on.
Page 48 Figure 11. MRI Mode screen 2. Tap Exit MRI Mode. The patient controller app disables MRI mode. The Therapy screen appears, showing that stimulation therapy is off. 3. To start stimulation, tap Therapy is OFF.
Page 49: Viewing And Selecting A Program
Viewing and Selecting a Program Tap the program name on the Therapy screen to open the Programs screen. On the Programs screen you can view and select any of the saved programs. To navigate between the saved programs, either: ▪ ▪...
Page 50 Figure 12. Programs screen 1. Cancel button 2. Program name 3. Left arrow 4. Right arrow 5. Program indicator 6. Select This Program button...
Page 51: Adjusting Program Strength
Table 3. Programs screen descriptions Screen Section Description or Button Name Cancel button Cancel to return to the Therapy screen. No program changes will be made. Program name Displays the program name of the current Programs screen. A check mark next to the program name indicates the currently selected program.
Page 52 the strength for all areas at the same time on the Grouped tab. To modify the strength for an area: 1. Tap the area you want to modify. The selected area displays with a white background and the stimulation map displays the affected area in dark blue.
Page 53 Figure 13. Strength screen Independent tab 1. Done button 2. Independent tab 3. Grouped tab 4. Selected Area 5. On or Off switch 6. Stimulation map 7. Increase button 8. Decrease button...
Page 54 To modify the strength for all areas: 1. Tap Grouped. 2. Tap the + or – buttons to increase or decrease strength for all areas. 3. The green bars below the area name will increase or decrease as you increase or decrease strength. 4.
Page 55 Figure 14. Strength screen Grouped tab 1. Done button 2. Independent tab 3. Grouped tab 4. On or Off switch 5. Stimulation map 6. Increase button 7. Decrease button...
Page 56 If you only have one area, you will see the following screen. Figure 15. Strength screen – One Area...
Page 57: System Information
Table 4. Strength screen descriptions Screen Section Description or Button Name Done button Done to save changes and return to the Therapy screen. Independent tab Selected by default. If you only have one area, you will not see the Independent tab. Grouped tab Grouped to view the Grouped tab.
Page 58 Figure 16. System information Generator screen 1. Done button 2. Manuals button 3. Generator button 4. Leads/Extensions button 5. Patient Controller button...
Page 59: Additional Patient Controller Information
Table 5. System information descriptions Screen Section Description or Button Name Done button Done to save changes and return to the Therapy screen. Manuals button Tap to view information about how to download the MRI Procedure Information manual. Generator Tap to view information about your button generator, such as the generator model number.
Page 60: Maintaining The Generator And Patient Controller
select Remove unless directed by your physician or Technical Support. Maintaining the Generator and Patient Controller This section provides tips and other information about maintaining and caring for your generator and patient controller. Checking the Generator Battery Status Refer to the IPG and EPG information below for instructions on viewing your generator battery status.
Page 61 NOTE: When the IPG battery is approaching the end of service a warning pops up on your patient controller app. To view the EPG battery status: As the battery is used, the generator battery indicator on the System screen shows the remaining life (the figure below shows the EPG battery indicator progression).
Page 62: Checking The Patient Controller Battery Status
Recharge the patient controller using only the Apple‡ charging cord and wall outlet plug provided with your device. When using the trial system, Abbott Medical does not recommend charging the provided patient controller with a computer since personal information may be transferred to the patient controller, which will be returned to Abbott Medical.
Page 63: Caring For The Patient Controller
Caring for the Patient Controller If you are using a patient controller provided by Abbott Medical, clean the protective case 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.
Page 64: Protecting Access To The Patient Controller
with important messages related to the cybersecurity of your patient device. Protecting Access to the Patient Controller To prevent unauthorized access to your Apple‡ device, set up a passcode or other supported method of biometric security (such as Touch ID‡ or Face ID‡). For instructions, refer to the user guide available at support.apple.com/manuals.
Page 65: Guidelines For Secure Use
▪ ▪ Proprietary authentication in addition to the pairing procedure specified in Bluetooth® Low Energy (LE) wireless technology, which includes an element of proximity. ▪ ▪ A proprietary algorithm that detects and prevents an unauthorized user from attempting to pair with the generator.
Page 66: Legal And Privacy Notice
Generators screen or view online at https://www.virtualclinic.abbott/policies. Abbott Medical is committed to protecting the privacy of our customers and patients. This privacy statement summarizes how we protect, gather, and use personal information of users. For more information, view our US or Global Privacy Policies online at www.abbott.com/privacy-policy.html.
Page 67: Troubleshooting
Technical Support. ▪ Refer to the terms and conditions for repair or ▪ replacement of Abbott Medical neurostimulation system components as stated in the Limited Warranty card included in your product documentation. Table 6. Possible causes and solutions for potential...
Page 68 Table 6. Possible causes and solutions for potential issues Problem Possible Cause Possible Solution Patient controller Patient controller app Open the App Store from app version is out of must be updated to the device and update date. work with the newer the patient controller generator software.
Page 69 Table 6. Possible causes and solutions for potential issues Problem Possible Cause Possible Solution Plug adapter or Replace the plug adapter charging cable is or charging cable. defective. Correct plug adapter Connect the appropriate (voltage converter) is plug adapter (voltage not connected to the converter) to the charger.
Page 70 Table 6. Possible causes and solutions for potential issues Problem Possible Cause Possible Solution Patient controller is Patient controller is off Wake up the patient not communicating or has timed out and is controller, see “Using a with the generator. in standby mode.
Page 71 Download the patient connect to the supported. controller app for your generator. system. Use the 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 72 Table 6. Possible causes and solutions for potential issues Problem Possible Cause Possible Solution Replace Generator The IPG is approaching Contact your clinician to Soon message its end of service and schedule a replacement. appears. will need to be replaced soon. Replace Generator The IPG has reached Contact your clinician to...
Page 73 Table 6. Possible causes and solutions for potential issues Problem Possible Cause Possible Solution the on-screen notification to exit MRI mode. Program strength is The generator could Try adjusting the off. not deliver the desired program strength. If the program strength. problem persists, contact your clinician.
Page 74 Table 6. Possible causes and solutions for potential issues Problem Possible Cause Possible Solution The user’s hand is Try holding the patient blocking the Bluetooth controller differently. wireless antenna. Bluetooth wireless Decrease the distance connection is not between the patient strong.
Page 75 Table 6. Possible causes and solutions for potential issues Problem Possible Cause Possible Solution may be causing interference. Move the patient controller and generator so they have a line of sight and maintain an uninterrupted path for the Bluetooth wireless technology signal.
Page 76: Technical Support
MRI mode. Technical Support For technical questions and support 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 Abbott Medical representative.
Page 77: Appendix A: Downloading The Patient Controller App
You must download the patient controller app to your patient controller (either a device provided by Abbott Medical or a compatible personal Apple‡ iOS‡ device) to use the patient controller with your generator. The patient controller app is compatible with...
Page 78: Appendix B: Pairing The Patient Controller To The Generator
Wi-Fi‡ network. 2. Tap the App Store icon on the patient controller Home screen. 3. Enter Abbott Patient Controller in the Search field. 4. Once you locate the correct app, follow the onscreen prompts. NOTE: If you encounter problems downloading the app, contact Technical Support.
Page 79 3. Tap The Add Generator screen opens. Figure 18. Add Generator screen 4. Tap an available generator in the “Select a 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.
Page 80: Appendix C: Regulatory Statements
6. Tap Pair to pair the patient controller and generator. The “Connecting to Generator…” message displays while the patient controller is connecting to the generator. Appendix C: Regulatory Statements These statements are applicable to the generator. For Regulatory Statements regarding the patient controller, refer to the user guide available at support.apple.com/manuals for the Apple‡...
Page 81: Statement Of Compliance With License-Exempt Rss Standard (Canada)
encouraged to try to correct the interference by one or more of the following measures: ▪ ▪ Reorient or relocate the receiving antenna. ▪ ▪ Increase the separation between the equipment and receiver. ▪ ▪ Connect the equipment into an outlet on a circuit different from that to which the receiver is connected.
Page 82: Television
interference, including interference that may cause undesired operation of the device. Declaration of Conformity (Industry Canada) Notice to Users of Radio and Television This Class B digital apparatus meets all the requirements 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:...
Page 83: Product Classification Statement (Cispr 11, Class B)
Table 8. Proclaim™ IPG Registration identification information Identifier Type Registration Identifier FCC Registration RIASJMRFC Number Industry Canada 8454A-M3660123 (IC) Registration Number Product Classification Statement (CISPR 11, Class 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®...
Page 84 Table 9. Bluetooth Low Energy (LE) wireless technology information EPG Antenna 4 mm x 3 mm x 1.1 mm dimensions IPG Antenna 8.1 mm x 5.1 mm x 4.9 mm dimensions Modulation GFSK EPG Magnetic Field 0.000145 A/m maximum Strength (at 10 m distance) IPG Magnetic Field 16.3 µA/m...
Page 85: Radio Transmitter, Cables, Transducers
Table 9. Bluetooth Low Energy (LE) wireless technology information Bandwidth 2 MHz per channel Data flow Bi-directional Protocol Bluetooth LE wireless technology *EIRP = Equivalent isotropically radiated power Radio Transmitter, Cables, Transducers The device contains a radio transmitter/receiver with the following parameters. Radio transmitter parameters: ▪...
Page 86: Quality Of Service For Wireless Technology
The radio receiver in the device is using the same frequency and bandwidth as the transmitter. Cables and transducers: Cables and transducers are not used during normal use of the device nor while programming the device. Quality of Service for Wireless Technology Bluetooth®...
Page 87 if not sent successfully. Each key press may transmit up to 4 data packets with up to 20 bytes per packet, depending on the number of packets that need to be transmitted (that is, if there is only one packet to transmit, only one packet will be transmitted).
Page 88: Appendix D: Electromagnetic Compatibility Guidelines
▪ ▪ Do not operate other wireless devices (such as laptop, tablet, mobile phone, or cordless phone) at the same time. NOTE: Wireless communication equipment (such as wireless home network devices, mobile and cordless telephones, and tablets) can affect the device.
Page 89 CAUTION: To avoid increasing emissions or decreasing immunity from a device or system, use only components approved by Abbott Medical with this system. Do not use Abbott Medical components with devices or systems that are not approved by Abbott Medical.
Page 90 Table 11. Guidance and Manufacturer’s Declaration – Electromagnetic Immunity Immunity IEC 60601 Compliance Electromag- Test Test Level Level netic Environment Guidance Electrostatic ±8 kV contact ±8 kV contact The relative discharge (ESD) humidity should ±15 kV air ±15 kV air IEC 61000-4-2 be at least 15%.
Page 91 Table 11. Guidance and Manufacturer’s Declaration – Electromagnetic Immunity Immunity IEC 60601 Compliance Electromag- Test Test Level Level netic Environment Guidance which radiated 6 Vrms (ISM/ 6 Vrms RF disturbances Radio bands are controlled. between The customer or 150 kHz to the user of the 80 MHz) device can help...
Page 92 Table 11. Guidance and Manufacturer’s Declaration – Electromagnetic Immunity Immunity IEC 60601 Compliance Electromag- Test Test Level Level netic Environment Guidance where P is the maximum power in watts (W), d is recommended separation distance in meters (m), and E is the immunity test level in volts per meter (V/m).
Page 93 Table 12. Guidance and Manufacturer’s Declaration – Proximity Fields Proximity IEC 60601 Compliance Electromag- Test Test Level Level netic Environment Guidance IEC 61000-4-3 385 MHz: 27 V/m Recommended 27 V/m @ 18 Hz minimum pulse separation modulation distance d = 0.3 m 450 MHz: 28 V/m 28 V/m @ FM...
Page 94: Radio Frequency Information
(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: ▪...
Page 95 ▪ ▪ 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.
Page 96 2022-08 ARTEN600266402 A *600266402*...