Abbott 3599 Clinician Manual
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Abbott 3599 Clinician Manual

Abbott 3599 Clinician Manual

Medical external pulse generator
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Abbott Medical External Pulse Generator
Spinal Cord Stimulation Systems
Model 3599
Clinician's Manual

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Summary of Contents for Abbott 3599

  • Page 1 Abbott Medical External Pulse Generator Spinal Cord Stimulation Systems Model 3599 Clinician's Manual...
  • 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 Prescription and Safety Information..........1 Intended Use.
  • Page 4 Securing the Leads or Extensions............23 Connecting the EPG Header to the EPG.
  • Page 5 Appendix C: Electromagnetic Compatibility Guidelines....... . . 40 Radio Frequency Information............. 45 Appendix D: Symbols and Definitions.

  • Page 7: Prescription And Safety Information

    Read this section to gather important prescription and safety information. Intended Use The St. Jude Medical™ invisible trial system is intended to be used externally with Abbott Medical-approved trial leads and extensions to deliver trial stimulation for a maximum of 30 days.
  • Page 8 from diathermy can be transferred through the implanted system and 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 system implantation and replacement.
  • Page 9 Lead movement. Patients should avoid bending, twisting, stretching, or lifting objects over 2 kg (5 lb) for six to eight weeks postimplantation. Extension of the upper torso or neck may cause lead movement and alter the stimulation field, resulting in overstimulation or ineffective stimulation. Operation of machines, equipment, and vehicles.

  • Page 10: Precautions

    The BurstDR™ stimulation mode has not been evaluated for effectiveness in the diabetic peripheral neuropathy (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.
  • Page 11 Excessive heat, traction, bending, and twisting, or the use of sharp instruments may damage components and cause them to fail. Package or component damage. Do not use the device if the package or components show signs of damage. Return any suspect components to Abbott Medical for evaluation.
  • Page 12 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. Component disposal. Dispose of the EPG header and pouch with other medical waste. Return the EPG to Abbott Medical for safe disposal when necessary.

  • Page 13: Adverse Effects

    explosives, or in hazardous locations. If you are unsure of the policy that applies to the use of this device, please ask for authorization to use it before turning it on. 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 device and generator;...

  • Page 14: Safety And Effectiveness Studies

    For information that supports the clinical use of this neurostimulation system, refer to the clinical summaries manual for spinal cord stimulation (SCS) systems (available online at medical.abbott/manuals). This neurostimulation system is similar in technology and intended use to the systems reported in the literature and clinical studies.

  • Page 15: Product Description

    Product Description The Abbott Medical External Pulse Generator (EPG) is an external trial generator that when connected to trial neurostimulation leads delivers therapeutic stimulation to parts of the body. The EPG communicates wirelessly with system programmers and controllers. The EPG header connects directly to the EPG for a neurostimulation trial. The EPG header can hold one or more leads or extensions with up to 16 electrodes total.

  • Page 16: Overview Of The Epg And Epg Header

    Overview of the EPG and EPG Header The following figures show the EPG and EPG header features. Figure 1. EPG features 1. Connector for multilead trial cable and EPG header 2. Battery compartment panel 3. Indicator light Figure 2. EPG header features 1.

  • Page 17: Package Contents

    Package Contents In addition to the product documentation, the External Pulse Generator, 16 channel kit (Model 3599) contains the following items: ▪ ▪ 1 EPG (Model 3599) ▪ ▪ 1 EPG header cap ▪ ▪ 1 battery door In addition to the product documentation, the External Pulse Generator, 2 Port Header kit (Model 3032) contains the following items: ▪...

  • Page 18: Overview Of The Epg Procedure

    Overview of the EPG Procedure The following steps provide a general overview of the EPG procedure. Refer to the following sections for more information about each of these steps. 1. Replace the EPG batteries. 2. Set up communication between the EPG and the clinician programmer and patient controller. 3.

  • Page 19: Replacing The Epg Batteries

    Replacing the EPG Batteries The EPG uses two nonrechargeable CR2450 coin cell batteries. Abbott Medical recommends replacing the batteries before starting a new trial and only using the batteries included in the External Pulse Generator, 2 Port Header. NOTE: Dispose of batteries safely. Do not treat them as household waste. Refer to the guidelines in Appendix B (page 34) for more information.
  • Page 20 Figure 3. Battery compartment panel 3. Remove the batteries by either: – turning the EPG over so the battery compartment is facing down and lightly tapping the EPG in the – – palm of your hand, or – pressing down on one side of the battery so the opposite side pops up, lifting the battery out, and –...
  • Page 21 Figure 4. Inserting batteries into the battery compartment 6. Place the battery compartment panel flush to the EPG, lining up the tabs with the coordinating indentation. Figure 5. Replacing the battery compartment panel...

  • Page 22: Checking The Status Of The Epg Batteries

    NOTE: Battery life depends on usage and stimulation settings, with batteries lasting at least 14 days under nominal or practical high output tonic settings, with 500 ohm impedance and stimulation on for 16 hours per day. (High output is based on actual patient use collected in Abbott Medical clinical studies, not the maximum device output.) The following information provides general guidelines for the battery status: ▪...

  • Page 23: Setting Up Communication Between The Epg And The Clinician Programmer And Patient Controller

    ▪ ▪ Stimulation will automatically turn off when the batteries cannot support stimulation. Replace the EPG’s batteries to communicate with the EPG, turn stimulation on, change stimulation settings, or retrieve stimulation usage information. NOTE: If the batteries deplete during a trial, instruct the patient to refrain from replacing the batteries to avoid disturbing the bandaging and lead position.

  • Page 24: Epg Indicator Light

    EPG Indicator Light The indicator light on the EPG will flash for the following reasons: ▪ ▪ When batteries are inserted into the EPG ▪ ▪ When a communication session with the clinician programmer app or patient controller app is started ▪...
  • Page 25 Figure 6. Magnet and keeper bar 1. Magnet 2. Keeper bar 2. Hold the magnet perpendicular to and centered directly over the EPG for 2 seconds. Figure 7. Holding the magnet over the EPG...

  • Page 26: Using The Epg

    3. Remove the magnet, replace the keeper bar, and store the magnet. CAUTION: Do not use the magnet around magnetically sensitive items to avoid damaging them. Using the EPG Read this section for directions for use related to the EPG and EPG header. For directions for use of other system components not covered in this document, see the clinician’s manual for the appropriate device.

  • Page 27: Connecting The Multilead Trial Cable To The Epg

    Connecting the Multilead Trial Cable to the EPG To connect a multilead trial cable to the EPG: NOTE: For further instructions, refer to the clinician’s manual for the multilead trial cable. 1. Remove the EPG header cap to expose the EPG stimulator port. 2.

  • Page 28: Disconnecting The Multilead Trial Cable From The Epg

    Figure 8. Inserting the connector into the EPG stimulator port Disconnecting the Multilead Trial Cable from the EPG To disconnect the multilead trial cable from the EPG: NOTE: For further instructions, refer to the clinician’s manual for the multilead trial cable. 1.

  • Page 29: Securing The Leads Or Extensions

    Securing the Leads or Extensions The following information 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 clinician’s manual for the applicable leads or extensions.

  • Page 30: Connecting The Epg Header To The Epg

    Connecting the EPG Header to the EPG To connect the EPG header to the EPG, align the tab indentation on the EPG header with the tab on the EPG and carefully insert the EPG header into the EPG body until it clicks into place. Figure 9.
  • Page 31 1. If any of the lead or extension contacts came in contact with body fluid or saline, thoroughly clean the contacts with sterile deionized water or sterile water for irrigation and dry them completely. CAUTION: Do not bend the lead sharply or it may be damaged. NOTE: The EPG header comes with open ports and attached port plugs.

  • Page 32: Securing The Epg

    Figure 10. Insert the lead or extension fully into the EPG header 1. Fully inserted 2. Not fully inserted 4. Release the button to lock the lead or extension into place. 5. If applicable, repeat the previous steps to insert the remaining lead or extension. Do not disturb the already inserted lead or extension.

  • Page 33: Programming The Epg

    3. Use the flap to secure the leads in place and seal the pouch. NOTE: The EPG meets the IP22 rating when sealed in the pouch. 4. Remove the adhesive liner on the back of the pouch and press the pouch onto the patient’s skin until it is secure.

  • Page 34: Cleaning The Epg

    ▪ ▪ Do not put heavy or sharp objects on the EPG. ▪ ▪ Keep the EPG away from food and beverages, and avoid getting the EPG wet. ▪ ▪ If the EPG does get wet, do not use it. Contact Technical Support for help. Cleaning the EPG ▪...
  • Page 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...

  • Page 36: Service And Ordering Information

    +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 Support. Refer to the following list for model numbers. Table 2. Ordering information for the EPG...

  • Page 37: Appendix A: Product Specifications

    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) has the following physical specifications. Table 3. EPG and EPG header specifications Height 79.8 mm (3.14 in.)
  • Page 38 Table 3. EPG and EPG header specifications Width 57.2 mm (2.25 in.) Thickness 11 mm (0.433 in.) Weight (with batteries) 44 g (1.55 oz) Volume 44.57 cc (2.72 cu in.) Power source Nonrechargeable CR2450 coin cell Lead or extension compatibility 2 Octrode™...
  • Page 39 Table 4. Operating parameters for the EPG Tonic Range Tonic Steps Burst Range* Burst Steps* Pulse width 50 - 500 µs 10 µs 50 - 1000 µs 50 µs Frequency 2 - 200 Hz 2 Hz — — 200 - 500 Hz 10 Hz 500 - 1200 Hz 20 Hz...

  • Page 40: Appendix B: Regulatory Statements

    Do not dispose of this device or its battery along with general waste. Follow local regulations for the safe disposal of the battery, and return the device to Abbott Medical at the end of its operating life. 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.

  • Page 41: Statement Of Compliance With License-Exempt Rss Standard (Canada)

    ▪ ▪ 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(s).

  • Page 42: Product Classification Statement (Cispr 11, Class B)

    Table 5. Registration identification information Identifier Type Registration Identifier Industry Canada (IC) 8454A-SJMX599EPG 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 43: Radio Transmitter, Cables, Transducers

    Table 6. Bluetooth® Low Energy (LE) wireless technology information Output power (EIRP*) 1 mW (0 dBm) typical, 10 mW (+10 dBm) maximum Range 2 meters typical Center frequency 2.44 GHz Channel 40 logical channels Bandwidth 2 MHz per channel Data rate 1 Mbit/s Data flow Bi-directional...

  • Page 44: Quality Of Service For Wireless Technology

    ▪ ▪ Modulation: GFSK ▪ ▪ Radiated output power: 10 mW (+10 dBm) maximum ▪ ▪ Magnetic field strength: 0.000145 A/m ▪ ▪ Duty Cycle: Variable, but low (<5%) ▪ ▪ Semi-duplex capability 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.
  • Page 45 transmission latency in each direction (2x), and a receive-to-transmit mode (RX‑to‑TX) time. Data is resent if not sent successfully. Each key press may transmit up to 8 data packets, 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 46 ▪ ▪ Move the devices away from other devices that may be causing interference. ▪ ▪ Close the clinician programmer or patient controller app, and turn the clinician programmer or patient controller off and on. ▪ ▪ Wait a few minutes and try connecting again. ▪...
  • Page 47 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. Table 7. Guidance and Manufacturer’s Declaration – Electromagnetic Emissions Emissions Test...
  • Page 48 Table 8. Guidance and Manufacturer’s Declaration – Electromagnetic Immunity Immunity Test IEC 60601 Test Level Compliance Level Electromagnetic Environment Guidance Electrostatic discharge (ESD) ±8 kV contact ±8 kV contact The relative humidity should be IEC 61000-4-2 at least 15%. ±15 kV air ±15 kV air Electrical fast transient/burst ±2 kV for power supply lines...
  • Page 49 Table 8. Guidance and Manufacturer’s Declaration – Electromagnetic Immunity Immunity Test IEC 60601 Test Level Compliance Level Electromagnetic Environment Guidance communications equipment Radiated RF IEC 61000-4-3 10 V/m 10 V/m (transmitters) and the device as 80 MHz to 2.7 GHz recommended below, according 80% AM at 1 kHz to the maximum output power of...
  • Page 50 Table 9. Guidance and Manufacturer’s Declaration – Proximity Fields Proximity Test IEC 60601 Test Level Compliance Level Electromagnetic Environment Guidance IEC 61000-4-3 385 MHz: 27 V/m @ 18 Hz pulse 27 V/m Recommended minimum modulation separation distance d = 0.3 m 450 MHz: 28 V/m @ FM 28 V/m modulation...
  • Page 51 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: ▪...
  • Page 52 Appendix D: Symbols and Definitions 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. Table 10. Symbols and definitions Symbol Definition Caution Refer to instruction manual/booklet...
  • Page 53 Table 10. Symbols and definitions Symbol Definition 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-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 solid foreign objects as small as 12.5 mm in diameter and is protected from...
  • Page 54 Table 10. Symbols and definitions Symbol Definition Use-by date Date of manufacture Manufacturing facility Temperature limit Humidity limitation Atmospheric pressure limitation...
  • Page 55 Table 10. Symbols and definitions 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 only Serial number...
  • Page 56 Unique Device Identification 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. By ensuring that 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.
  • Page 57 Table 10. Symbols and definitions Symbol Definition conformity is available at the following internet address: www.neuromodulation.abbott/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) Regulatory Compliance Mark (RCM) This equipment is certified for type certification pursuant of Article 38‑24 of...
  • Page 60 2023-02 ARTEN600279452 A *600279452*...

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