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Keep dry to avoid damage.

 Clinician programmers, patient controllers, and chargers are not waterproof.

Keep them dry to avoid damage. Advise patients to not use their devices when engaging in activities that

might cause them to get wet, such as swimming or bathing.

Pediatric use.

 Safety and effectiveness of neurostimulation for pediatric use have not been established.

Pregnancy and nursing. 

Safety and effectiveness of neurostimulation for use during pregnancy and nursing

have not been established.

Device 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.

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. Only apply software updates that are published directly by Abbott Medical.

Case damage.

 Do not handle the generator if the case is pierced or ruptured because severe burns could

result from exposure to battery chemicals.

Generator disposal.

 Return all explanted generators to Abbott Medical for safe disposal. generators contain

batteries as well as other potentially hazardous materials. Do not crush, puncture, or burn the generator

because explosion or fire may result.

Product materials. 

Neurostimulation systems have materials that come in contact or may come in contact

with tissue. A physician should determine whether or not a patient may have an allergic reaction to these

materials before the system is implanted.

Precautions

The following precautions apply to this neurostimulation system.

General Precautions

Clinician training.

 Implanting physicians should be experienced in the diagnosis and treatment of chronic

pain syndromes and have undergone surgical and device implantation training.

Patient selection.

 It is extremely important to select patients appropriately for neurostimulation. Thorough

psychiatric screening should be performed. 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 generator over

an incision that has not completely healed. Infections related to system implantation might require that the

device be explanted.

Implantation of two systems.

 If two systems are implanted, ensure that at least 20 cm (8 in.) separates the

implanted generators to minimize unintended interaction with other system components.

Implantation of multiple leads.

 If multiple leads are implanted, leads and extensions should be routed in

close proximity. Nonadjacent leads can possibly create a conduit for stray electromagnetic energy that could

cause the patient unwanted stimulation.

Implant heating. 

While charging the generator, patients may perceive an increase in temperature at the

generator site. In patients who have areas of increased sensitivity to heat, consider placing the implant

where the patient has normal sensation.

High stimulation outputs.

 Stimulation at high outputs may cause unpleasant sensations or motor

disturbances or render the patient incapable of controlling the generator. If unpleasant sensations occur,

turn off stimulation immediately.

Electromagnetic interference (EMI). 

Some equipment in home, work, medical, and public environments can

generate EMI that is strong enough to interfere with the operation of a neurostimulation system or damage

system components. Patients should avoid getting too close to these types of EMI sources, which include

the following examples: commercial electrical equipment (such as arc welders and induction furnaces),

communication equipment (such as microwave transmitters and high-power amateur transmitters), high-

voltage power lines, radiofrequency identification (RFID) devices, and some medical procedures (such as

therapeutic radiation and electromagnetic lithotripsy).

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;

however, it will not change the prescribed programmed parameters. Patients should be advised to keep

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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...

Страница 25: ...21...

Страница 26: ......

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

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