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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® Low Energy enables communication between the generator and the clinician programmer or

patient controller. The quality of the wireless communication link varies depending on the use environment

(operating room, recovery room, and home environment).
After the clinician programmer or patient controller is paired with a generator, the Bluetooth® wireless

technology symbol is visible on the clinician programmer or patient controller in the upper right-hand

corner of the screen. When Bluetooth® Low Energy is not active, the symbol appears dimmed.
The quality of service (QoS) should allow wireless data to be transferred at a net rate of 2.5 kB/sec. Each

connection interval includes a semi-duplex transmission with a required acknowledge, a transmission

latency in each direction (2x), and a receive-to-transmit mode (RX-to-TX) time. Data is resent if not

successfully received. Each key press may transmit up to 4 data packets with up to 20 bytes per packet,

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). If the interference is high (for example, the bit error rate

exceeds 0.1%), the user may experience what appears to be a slow connection, difficulty pairing devices,

and a need to decrease the distance between connected devices. For information on how to improve

connection 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 following:

The generator encrypts its wireless communication with the programming device using a key that is

unique to that link.

Only one patient controller or clinician programmer may communicate with the generator at a time.


Standard Bluetooth® Low Energy pairing methods ensure valid and legitimate pairing among devices.


Proprietary authentication for the patient controller or clinician programmer applications in addition to

the pairing procedure specified in Bluetooth® Low Energy, which includes an element of proximity.

A proprietary algorithm that detects and prevents an unauthorized application from communicating

with the generator.

Whitelisting methods that prevent unauthorized devices from using Bluetooth® Low Energy scanning to

interfere with communication from the generator to a legitimate patient controller or clinician

programmer.

Troubleshooting for Wireless and Coexistence Issues

If you experience issues with the wireless communication between the generator and the clinician

programmer or patient controller, try the following:

Decrease the distance between the devices.


Move the devices so they share line of sight.


Move the devices away from other devices that may be causing interference.


Close the clinician programmer or patient controller app; then turn the clinician programmer or patient

controller off and on.

Wait a few minutes and try connecting again.


Do not operate other wireless devices, such as a laptop, tablet, mobile phone, or cordless phone at the

same time.
NOTE: Wireless communication equipment, such as wireless home network devices, mobile and

cordless telephones, and tablets, can affect the device.

17

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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