Table of Contents
Advertisement
Quick Links
Advertisement
Table of Contents
Related Manuals for Abbott Eterna 32400
Summary of Contents for Abbott Eterna 32400
- Page 1 Eterna™ Implantable Pulse Generator Model 32400 Clinician's Manual...
- Page 2 State of California to cause cancer and birth defects or other reproductive harm. For more information, go to www.P65Warnings.ca.gov. ™ Indicates a trademark of the Abbott group of companies. ‡ Indicates a third-party trademark, which is property of its respective owner.
-
Page 3: Table Of Contents
Adapters and Extensions for Compatibility with Non-Abbott Leads........ -
Page 5: Prescription And Safety Information
A physician can help determine if a patient is eligible to receive an MRI scan by following the requirements provided by Abbott Medical. Physicians should also discuss any risks of MRI with patients. - Page 6 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. Injury or damage can occur during diathermy treatment whether the neurostimulation system is turned on or off.
-
Page 7: Precautions
Device modification. This equipment is not serviceable by the customer. To prevent injury or damage to the system, do not modify the equipment. If needed, return the equipment to Abbott Medical for service. Application modification. To prevent unintended stimulation, do not modify the generator software in any way. - Page 8 Do not implant a device if the sterile package, the device, or any device components show signs of damage, tampering, or if the sterile seal is ruptured, or contamination is suspected for any reason. Return any suspect components to Abbott Medical for evaluation. Exposure to body fluids or saline.
-
Page 9: Adverse Effects
Patients with implanted Abbott leads should avoid scuba diving in more than 30 m (100 ft) of water or entering hyperbaric chambers above 4.0 atmospheres absolute (ATA) for any length of time, as this may damage the neurostimulation system. -
Page 10: Product Description
▪ ▪ Compatibility. The generator header is designed to allow the generator to connect to an Abbott adapter so compatible leads or extensions from another manufacturer can be used with the Eterna™ SCS system. Refer to the compatibility guidelines in this manual (see “Adapters and Extensions for... -
Page 11: Package Contents
The generator has a radiopaque identification tag in the lower right corner that can be viewed with standard X-ray procedures. On the tag, ABT identifies Abbott Medical as the manufacturer, and the letter and a number combination A2 identifies the model family. Additionally, the header port plug is radiopaque and, if used, is visible with standard x‑ray procedures (see the following figure). -
Page 12: Connecting A Lead Or Extension To The Generator
2. Create the pocket so that the generator is parallel to the skin surface. Ensure the pocket is at least 0.5 cm (0.20 in.) below the surface of the skin but does not exceed a depth of 2.5 cm (0.98 in.). 3. -
Page 13: Implanting The Generator
5. Insert the torque wrench through the septum and tighten the setscrew, turning it clockwise until the torque wrench clicks. NOTE: After removing the torque wrench, check the septum to ensure it has closed. If the septum did not close, gently reseat the septum flaps. Figure 4. -
Page 14: Replacing The Generator
Extension to the Generator” (page 8) and “Implanting the Generator” (page 9). Disposing of Explanted Components Explanted Abbott Medical components should be returned to Abbott Medical for proper disposal. To return an explanted component, place it in a container or bag marked with a biohazard label and coordinate the return with your Abbott Medical representative or Technical Support. -
Page 15: Appendix A: Product Specifications
Appendix A: Product Specifications Storage and Excursion Temperature Specifications Store the components in this kit according to the following recommended conditions. Table 1. Recommended storage and excursion conditions for components Long Term Storage Temperature Store at 23°C or 73°F Temperature Excursions Excursions below 15°C (59°F) or above 30°C (86°F) should be <24 hours in duration Excursion Temperature Limits... -
Page 16: Adapters And Extensions For Compatibility With Non-Abbott Leads
NOTE: The maximum current depends on the impedance, frequency, and pulse width settings. Adapters and Extensions for Compatibility with Non-Abbott Leads The Eterna™ implantable pulse generator is compatible with select Medtronic leads and extensions. However, a compatible adapter or extension must be used to connect the Eterna™ implantable pulse generator to Medtronic leads. -
Page 17: Appendix B: System Components And Accessories
NOTE: Not all models are available in all countries. Contact your local representative for more information. NOTE: 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. -
Page 18: Leads And Extensions
Model Description 35500 SCS patient controller kit Leads and Extensions Model Description 3100-series Percutaneous leads 3200-series Paddle leads 3300-series Extensions Leads and Extensions Accessories Model Description 1100-series Stylets 1102 Guidewire for percutaneous leads 1103 Introde-AK™ lead introducer 1105 Lead anchor, butterfly 1106 Lead anchor, long 1109... -
Page 19: Appendix C: Generator Battery Information
Sorting such waste and removing it from other forms of waste lessens the contribution of potentially toxic substances into municipal disposal systems and into the larger ecosystem. 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 20: Identification Information For Product Registration
interference in a residential installation. This equipment generates, uses, and can radiate radiofrequency energy and, if not installed and used in accordance with the instructions, may cause harmful interference to radio communications. However, there is no guarantee that interference will not occur in a particular installation. -
Page 21: 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 22: Appendix E: Symbols And Definitions
Appendix E: 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 8. Symbols and definitions Symbol Definition Caution Consult instructions for use... - Page 23 European conformity, affixed according to the relevant provisions of European Council Regulation 2017/745 (NB 2797) and RE directive 2014/53/EU Annex II. Hereby, Abbott Medical declares that this device complies with the relevant provisions of this regulation and directive. The full text of the European Union RE directive 2014/53/EU declaration of conformity is available at the following internet address: www.neuromodulation.abbott/euconformity.
- Page 24 Table 8. Symbols and definitions Symbol Definition This equipment is certified for type certification pursuant of Article 38‑24 of the Japan Radio Law...
- Page 28 2022-09 ARTEN600144282 B *600144282*...