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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:

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USA: FCC 47 CFR Part 15:2012

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Canada: RSS

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210 Issue 8

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Europe: ETSI EN 301 489-1 V2.2.0 (2017-03) and ETSI EN 301 489-17 V3.2.0 (2017-03)

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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 device will not receive

interference or that any particular transmission from this device will be free from interference.

Содержание 3599

Страница 1: ...Abbott Medical External Pulse Generator Spinal Cord Stimulation Systems Model 3599 Clinician s Manual...

Страница 2: ...hysician 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 Bl...

Страница 3: ...Contents 11 Getting Started 11 Overview of the EPG Procedure 12 Replacing the EPG Batteries 13 Checking the Status of the EPG Batteries 16 Setting Up Communication Between the EPG and the Clinician P...

Страница 4: ...Appendix A Product Specifications 31 EPG with Header 31 Appendix B Regulatory Statements 34 Disposal Guidelines for Battery Powered Devices 34 Statement of FCC Compliance 34 Statement of Compliance W...

Страница 5: ...Appendix C Electromagnetic Compatibility Guidelines 40 Radio Frequency Information 45 Appendix D Symbols and Definitions 46 iii...

Страница 6: ...iv...

Страница 7: ...ions This neurostimulation system is contraindicated for patients who are unable to use the system Neurostimulation should not be used on patients who are poor surgical risks such as those with multip...

Страница 8: ...issue at the electrode site and cause severe injury to the patient If use of electrocautery is necessary first turn off the neurostimulation system Implanted cardiac systems Physicians need to be awar...

Страница 9: ...torized vehicles machinery or equipment Postural changes Changes in posture or abrupt movements can change the level of stimulation and potentially cause unpleasant sensations Patients should turn sti...

Страница 10: ...pathy DPN population System components The use of components not approved for use by Abbott Medical with this system may result in damage to the system and increased risk to the patient Power supply U...

Страница 11: ...turn off the EPG and proceed with caution being sure to move through the detector quickly Implantation of multiple leads If multiple leads are implanted leads and extensions should be routed in close...

Страница 12: ...omputerized tomography CT scans cobalt machines and linear accelerators If radiation therapy is required disconnect the EPG from the leads or extensions Damage to the system may not be immediately det...

Страница 13: ...onsider disabling magnet mode For more information about setting the magnet mode refer to the clinician programmer manual or contact Technical Support Adverse Effects The use of a neurostimulation sys...

Страница 14: ...ty of any surgical complication may be greater in patients with diabetes particularly those with inadequate pre operative glycemic control For adverse effects observed in SCS clinical studies refer to...

Страница 15: ...pins and needles prickling or even burning called paresthesia Paresthesia may be brief or it may last a long time For more information about the neurostimulation system see the clinician s programmin...

Страница 16: ...how the EPG and EPG header features Figure 1 EPG features 1 Connector for multilead trial cable and EPG 1 header 2 Battery compartment panel 2 3 Indicator light 3 Figure 2 EPG header features 1 Button...

Страница 17: ...ct documentation the External Pulse Generator 2 Port Header kit Model 3032 contains the following items 1 EPG header 2 CR2450 Batteries Cleaning cloths 1 EPG pouch with adhesive Getting Started This s...

Страница 18: ...extensions 3 4 Connect the leads or extensions to the multilead trial cable 4 5 Connect the multilead trial cable to the EPG 5 6 Test the system 6 7 Disconnect the multilead trial cable from the EPG 7...

Страница 19: ...as household waste Refer to the guidelines in Appendix B page 34 for more information To replace the batteries 1 Disconnect the EPG header or multilead trial cable from the EPG if either is connected...

Страница 20: ...your hand or pressing down on one side of the battery so the opposite side pops up lifting the battery out and repeating the process with the remaining battery 4 Insert a new battery into the battery...

Страница 21: ...nserting batteries into the battery compartment 6 Place the battery compartment panel flush to the EPG lining up the tabs with the coordinating 6 indentation Figure 5 Replacing the battery compartment...

Страница 22: ...ler app Refer to the clinician s programming or user s controller manual for these directions NOTE Battery life depends on usage and stimulation settings with batteries lasting at least 14 days under...

Страница 23: ...nt controller The following steps outline the procedure for setting up communication For further instructions refer to the clinician s programming manual 1 Place the magnet perpendicular to and center...

Страница 24: ...G is ready to pair with the clinician programmer or patient controller NOTE The EPG indicator light flashes faster when it is ready to pair than when batteries are inserted or a communication session...

Страница 25: ...Figure 6 Magnet and keeper bar 1 Magnet 1 2 Keeper bar 2 2 Hold the magnet perpendicular to and centered directly over the EPG for 2 seconds 2 Figure 7 Holding the magnet over the EPG 19...

Страница 26: ...the programmer and controller to ensure it is functional Refer to Setting Up Communication Between the EPG and the Clinician Programmer or Patient Controller page 17 for instructions CAUTION Before th...

Страница 27: ...ader cap to expose the EPG stimulator port 1 2 Carefully slide the connector end of the multilead trial cable into the EPG stimulator port 2 CAUTION The EPG is not sterile When connecting and testing...

Страница 28: ...ect the multilead trial cable from the EPG NOTE For further instructions refer to the clinician s manual for the multilead trial cable 1 Turn off stimulation on the EPG using the clinician programmer...

Страница 29: ...ation outlines the suggested procedure for securing the leads or extensions to the patient Secure the leads or extensions and bandage the lead entry site For further instructions refer to the clinicia...

Страница 30: ...the EPG header into the EPG body until it clicks into place Figure 9 Connecting the EPG header to the EPG Connecting the Leads or Extensions to the EPG Header To connect a lead or extension to the EPG...

Страница 31: ...er comes with open ports and attached port plugs Do not remove the port plugs from the header If only using one lead or extension use the lower port labeled 1 8 and insert a port plug in the unused po...

Страница 32: ...to lock the lead or extension into place 4 5 If applicable repeat the previous steps to insert the remaining lead or extension Do not disturb the 5 already inserted lead or extension Securing the EPG...

Страница 33: ...e patient 5 Use additional medical tape to secure the pouch and leads or extensions further as needed 5 Programming the EPG Use the clinician programmer app to program the system for the trial period...

Страница 34: ...not wipe over the stimulator port Do not submerge the EPG in fluid or use a cloth that is soaking wet Never use ammonia acidic or alkaline cleaners or organic chemicals such as paint thinner acetone p...

Страница 35: ...At the end of a trial disable stimulation clean the EPG and attach the header cap before storing the EPG NOTE During a trial store the header cap for reuse Figure 11 EPG header cap 29...

Страница 36: ...nformation 1 855 478 5833 toll free within North America 1 651 756 5833 For additional assistance call your local Abbott Medical representative Ordering Information To order parts contact Technical Su...

Страница 37: ...1216 EPG header cap 1213 Pouch with adhesive 5 1214 Pouch without adhesive and belt 5 1218 Carrying case Appendix A Product Specifications EPG with Header The EPG Model 3599 and EPG header Model 3032...

Страница 38: ...Nonrechargeable CR2450 coin cell Lead or extension compatibility 2 Octrode leads Expected service life 5 years Storage temperature 25 C 70 C 13 F 158 F Operating temperature 5 C 40 C 41 F 104 F Stora...

Страница 39: ...frequency 10 60 Hz 10 Hz Intra Burst frequency 250 500 Hz 500 1000 Hz 10 Hz 20 Hz Amplitude 0 25 5 mA 0 1 1 0 mA 0 12 75 mA 0 05 0 50 mA Stimulation output Constant current Constant current NOTE Colu...

Страница 40: ...and if not installed and used in accordance with the instructions may cause harmful interference to radio communications However there is no guarantee that interference will not occur in a particular...

Страница 41: ...he following two conditions 1 this device may not cause interference and 2 this device must accept any interference including interference that may cause undesired operation of the device Statement of...

Страница 42: ...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 T...

Страница 43: ...2 MHz per channel Data rate 1 Mbit s Data flow Bi directional Protocol Bluetooth LE wireless technology EIRP Equivalent isotropically radiated power Radio Transmitter Cables Transducers The device co...

Страница 44: ...and the clinician programmer or patient controller The requirements for the quality of service QoS vary depending on the use environment operating room recovery room and home environment After the cl...

Страница 45: ...ommunicate with the generator at the same time A unique key for each unit that is checked during each transmission Built in pairing that specifies valid and legitimate pairing among units Proprietary...

Страница 46: ...device Appendix C Electromagnetic Compatibility Guidelines The EPG hereafter the device is medical equipment and should be used with the following guidance The device requires special precautions with...

Страница 47: ...are not approved by Abbott Medical Table 7 Guidance and Manufacturer s Declaration Electromagnetic Emissions Emissions Test Compliance Electromagnetic Environment Guidance RF emissions CISPR 11 Group...

Страница 48: ...tery 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...

Страница 49: ...rding to the maximum output power of the communications equipment Recommended minimum separation distance for higher immunity test levels where P is the maximum power in watts W d is the recommended s...

Страница 50: ...dulation 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 pul...

Страница 51: ...low the limits as specified in USA FCC 47 CFR Part 15 2012 Canada RSS 210 Issue 8 Europe ETSI EN 301 489 1 V2 2 0 2017 03 and ETSI EN 301 489 17 V3 2 0 2017 03 NOTE Maintain a reasonable distance betw...

Страница 52: ...ct or product label For harmonized symbols refer to the Universal Symbols Glossary at medical abbott manuals Table 10 Symbols and definitions Symbol Definition Caution Refer to instruction manual book...

Страница 53: ...other persons within an MR environment Non ionizing electromagnetic radiation Keep dry keep away from rain Do not re use Ingress protection rating for a device that is protected from the intrusion of...

Страница 54: ...Table 10 Symbols and definitions Symbol Definition Use by date Date of manufacture Manufacturing facility Temperature limit Humidity limitation Atmospheric pressure limitation 48...

Страница 55: ...finitions Symbol Definition Do not use if package is damaged Catalog number NOTE This symbol also refers to the model number Manufacturer Packaging unit Implantable device Accessories Prescription use...

Страница 56: ...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 Abbo...

Страница 57: ...ott euconformity This device is listed by Nationally Recognized Testing Laboratory NRTL as certified Australian Communications and Media Authority ACMA and New Zealand Radio Spectrum Management RSM Re...

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Страница 60: ...2023 02 ARTEN600279452 A 600279452...

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