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their mobile phones and smart watches at least 15 cm (6 in.) away from the generator and avoid placing any

smart device in a pocket near the generator. If a patient is concerned about a smart device interacting with

their neurostimulation system, consider disabling magnet mode. For more information about setting the

magnet mode, refer to the clinician programmer manual or contact Technical Support.

Lead movement. 

Patients should be instructed to avoid bending, twisting, stretching, and lifting objects

over 2 kg (5 lb) for six to eight weeks after implantation of a neurostimulation system. Extension of the

upper torso or neck may cause lead movement and alter the stimulation field (especially with leads in the

cervical area), resulting in overstimulation or ineffective stimulation.

Patient training.

 Instruct patients to use their neurostimulation system only after an authorized clinician has

programmed the generator and has trained the patient on how to safely control stimulation and to charge

the system.

Programmer use.

 Allow only authorized use of the clinician programmer to avoid any programming changes

that may injure a patient.

Sterilization and Storage

Single-use, sterile device.

 The implanted components of this neurostimulation system are intended for a

single use only. Sterile components in this kit have been sterilized using ethylene oxide (EtO) gas before

shipment and are supplied in sterile packaging to permit direct introduction into the sterile field. Do not

resterilize or reimplant an explanted system for any reason.

Storage environment.

 Store components and their packaging where they will not come in contact with

liquids of any kind.

Handling and Implementation

Expiration date.

 An expiration date (or “use-before” date) is printed on the packaging. Do not use the

system if the use-before date has expired.

Recharge-by date.

 A recharge-by date is printed on the packaging. If this date has been reached or has been

exceeded before the date of implantation, the generator should be charged prior to implantation.

Handle devices with care.

 The clinician programmer and patient controller are sensitive electronic devices

that can be damaged by rough handling, such as dropping 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 the use of sharp

instruments may damage and cause failure of the components.

Package or component damage.

 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.

 Exposure of the metal contacts, such as those on the connection end of a

lead or extension, to body fluids or saline prior to connection can lead to corrosion. If such exposure occurs,

clean the affected parts with sterile, deionized water or sterile water for irrigation, and dry them completely

prior to lead connection and implantation.

System testing.

 To ensure correct operation, always test the system during the implant procedure, before

closing the neurostimulator pocket, and before the patient leaves the surgery suite.

Hospital and Medical Environments

High-output ultrasonics and lithotripsy.

 The use of high-output devices, such as an electrohydraulic

lithotriptor, may damage the electronic circuitry of an implanted generator. If lithotripsy must be used, do

not focus the energy near the generator.

Ultrasonic scanning equipment.

 The use of ultrasonic scanning equipment may cause mechanical damage

to an implanted neurostimulation system if used directly over the implanted system.

External defibrillators.

 Safety for use of external defibrillator discharges on a patient receiving

neurostimulation has not been established. External defibrillation can cause induced currents in the lead-

extension portion of the neurostimulation system. After defibrillation, confirm the neurostimulation system

is still working.

Therapeutic radiation.

 Therapeutic radiation may damage the electronic circuitry of an implanted

neurostimulation system, although no testing has been done and no definite information on radiation

effects is available. Sources of therapeutic radiation include therapeutic X rays, cobalt machines, and linear

accelerators. If radiation therapy is required, the area over the implanted generator should be shielded with

lead. Damage to the system may not be immediately detectable.

4

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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