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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. If this equipment does cause harmful interference to radio or television reception, which can be

determined by turning the equipment off and on, the user is 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.

Consult the dealer or an experienced radio/TV technician for help.

Operation is subject to the following two conditions:

This device may not cause harmful interference.


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.

Identification Information for Product Registration

This device has a label that contains, among other information, a product identifier in the following format:

Table 6. Registration identification information

Identifier Type

Registration Identifier

FCC registration number

PX2-GMIPG1

Wireless Technology Information

The following table summarizes the technical details of the Bluetooth® Low Energy as it is implemented in

the device.

Table 7. Bluetooth® Low Energy information

Antenna type

Modified monopole

Antenna dimensions

10.7 mm x 4.3 mm x 3.0 mm

Modulation

GFSK

Output power (EIRP*)

2 mW (+3 dBm) typical

Duty cycle

14.1% or less over 6 min period

Range

Up to 2 m typical

Center frequency

2.44 GHz

Channel frequency range

2.402 GHz to 2.480 GHz

Channel

40 logical channels using AFH

Bandwidth per channel

2 MHz

Data flow

Bi-directional

Protocol

Bluetooth® Low Energy

Semi-duplex capability

Yes

*EIRP = Equivalent isotropically radiated power (not duty cycle adjusted)

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Summary of Contents for Eterna 32400

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

Page 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...

Page 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...

Page 4: ...ii...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

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 20...

Page 25: ...21...

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

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