Inspire 4063 - Precautions

Inspire System Models 3024, 4063, 4323 English 13
200-079-101 Rev A
3024EN_ch.fm 5/6/14 10:31 pm
4.625 x 6 inches (117 mm x 152 mm)
Inspire Medical Confidential
Precautions
General
• Pediatrics — The safety of implantation and the parameters for safe and effective
stimulation of the hypoglossal nerve have not been evaluated in clinical studies for patients
less than 22 years of age. There may be increased risk of nerve injury and stimulation-
related adverse events in this population, particularly in younger children (e.g., less than
12 years of age).
• Expiration date — Do not use any Inspire system product after its expiration date.
• Component handling — Precautions related to component handling during the implant
procedure are located on page 18.
• Storage temperature ranges
– Do not expose the IPG to temperatures above 52°C (125°F) or below -18°C (0°F).
– Do not expose the leads to temperatures above 55°C (131°F) or below -10°C (14°F).
Electromagnetic compatibility and medical procedures
For information on MRI and diathermy, see “Warnings” on page 12.
The IPG is designed to ensure immunity from most common sources of electromagnetic
disturbance. In most cases, turning off the electromagnetic disturbance source, or moving away
from the electromagnetic disturbance source will return the IPG to normal operation. Extremely
strong sources of electromagnetic disturbance could interfere with normal IPG operation,
causing the IPG to reset and requiring the IPG to be reconfigured. To reduce the possibility of
electromagnetic interference (EMI), patients are recommended to use therapy only while
asleep.
Medical environment
Electrocautery, irradiation, lithotripsy, RF-ablation, X-ray, and fluoroscopy are typical
electromagnetic disturbance sources in hospital and clinical environments. Medical treatments
that use ultrasonics, defibrillation, or radiation can adversely affect the Inspire system.
• Electrocautery — Electrocautery may induce failure of the IPG. Alternatives to
electrocautery should be used when available. Bipolar electrocautery should be used if
alternatives are not available. If electrocautery must be used in the vicinity of the IPG,
therapy should be turned off.
• Radiation therapy — The IPG should not be directly irradiated by therapeutic levels of
ionizing radiation (such as produced by cobalt machines or linear accelerators used for
cancer treatment) because of the risk of permanent damage to the IPG circuitry. If such
therapy is required in the vicinity of the IPG, shield the device and confirm its function after
treatment.
• RF-ablation — RF-ablation should not be used directly over the implant sites.
• X-ray and fluoroscopy — Exposure to diagnostic X-ray or fluoroscopic radiation should
not affect the IPG or leads.
• Therapeutic ultrasound — Exposure to high ultrasonic frequencies may result in damage
to the IPG or leads. It is not recommended to use high-output ultrasonic devices, such as
an electrohydraulic lithotriptor or bone growth stimulator on patients with an implanted IPG.