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Eterna™ Implantable Pulse Generator

Model 32400

Clinician's Manual

Содержание Eterna 32400

Страница 1: ...Eterna Implantable Pulse Generator Model 32400 Clinician s Manual...

Страница 2: ...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...

Страница 3: ...xcursion Temperature Specifications 11 Product Materials 11 Generator Specifications 11 Adapters and Extensions for Compatibility with Non Abbott Leads 12 Appendix B System Components and Accessories...

Страница 4: ...ii...

Страница 5: ...sting of conditionally approved components refer to the MRI procedures clinician s manual for neurostimulation systems available online at medical abbott manuals For more information about MR Conditio...

Страница 6: ...t with the sensing operation of an implanted cardiac system causing the cardiac system to respond inappropriately To minimize or prevent the implanted cardiac system from sensing the output of the neu...

Страница 7: ...ed Patients should not be dependent on drugs and should be able to operate the neurostimulation system Infection Follow proper infection control procedures Patients should avoid charging their generat...

Страница 8: ...g them on the ground Care and handling of components Use extreme care when handling system components prior to implantation Excessive heat excessive traction excessive bending excessive twisting or th...

Страница 9: ...0 minutes are recommended Wireless use restrictions In some environments the use of wireless functions for example Bluetooth wireless technology may be restricted Such restrictions may apply aboard ai...

Страница 10: ...etooth wireless technology NOTE This manual provides instructions for implanting the generator For instructions for using other components or more information about the neurostimulation system see the...

Страница 11: ...ician s manual for the clinician programmer NOTE Before the surgical procedure set up communication between the clinician programmer and the generator while the generator is in its sterile packaging t...

Страница 12: ...er Retracting the setscrew too far may cause it to come loose and fail to secure the lead or extension to the generator CAUTION To avoid sharply bending and damaging the lead or extension when perform...

Страница 13: ...nd the generator in loops no smaller than 2 2 5 cm 0 98 in in diameter to provide strain relief for the lead or extension and generator connection CAUTION Do not bring the suture needle in contact wit...

Страница 14: ...rt Checking the Status of the Generator Battery The generator contains a rechargeable battery The amount of time that the battery will provide active stimulation depends on the patient s stimulation s...

Страница 15: ...ial Generator Titanium silicone rubber epoxy resin Pocket sizer Polybutylene terephthalate Port plug Polyether ether ketone PEEK with barium sulfate NOTE These components are not made with natural rub...

Страница 16: ...onic program governs the maximum frequency 1200 number of stim sets NOTE The maximum current depends on the impedance frequency and pulse width settings Adapters and Extensions for Compatibility with...

Страница 17: ...or Model Description 32400 Eterna implantable pulse generator Generator Accessories Model Description 1101 Torque wrench 12710 Port plug Charging System Model Description 16000 Charger Charging System...

Страница 18: ...lead introducer 1105 Lead anchor butterfly 1106 Lead anchor long 1109 Strain relief 1112 Tunneling tool 12 in 1114 Epidural needle 14 gauge 4 in 10 cm 1116 Epidural needle 14 gauge 6 in 15 cm 1120 Tu...

Страница 19: ...sessions between the generator and the patient controller or clinician programmer If the generator was stored outside of recommended storage temperatures Nominal stimulation settings for BurstDR prog...

Страница 20: ...nterference 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 F...

Страница 21: ...n issues please refer to Troubleshooting for Wireless and Coexistence Issues page 17 Wireless Security Measures The wireless signals are secured through device system design that includes the followin...

Страница 22: ...onstrated 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...

Страница 23: ...n the European Community 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 dec...

Страница 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 20...

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Страница 28: ...2022 09 ARTEN600144282 B 600144282...