12 English Inspire System Models 3024, 4063, 4323
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
Warnings and Precautions
Warnings
•Training — Physicians must be trained in the proper use and surgical procedure before
implantation or operation of the device.
• Pediatrics — The majority of cases of obstructive sleep apnea in younger pediatric
patients (e.g., less than 18 years of age) result from anatomical obstruction (e.g.,
adenotonsillar hypertrophy) that would not be appropriately managed with
neurostimulation therapy.
• Components — The use of components not provided by Inspire Medical Systems may
result in damaged components, improper operation, or increased risks to the patient.
• Diathermy — Do not use shortwave diathermy, microwave diathermy or therapeutic
ultrasound diathermy (all now referred to as diathermy) on patients implanted with a
neurostimulation system. Energy from diathermy can be transferred through the implanted
system and can cause tissue damage at the location of the implanted electrodes, resulting
in severe injury or death.
Diathermy can also damage the neurostimulation system components, resulting in loss of
therapy and requiring additional surgery for system explantation and replacement. Advise
your patient to inform all their health care professionals that they should not be exposed
to diathermy treatment.
Injury to the patient or damage to the device can occur during diathermy treatment when:
• The neurostimulation system is turned on or off
• Diathermy is used anywhere on the body—not just at the location of the
neurostimulation system
• Diathermy delivers heat or no heat
• Any component of the neurostimulation system (lead, extension, neurostimulator)
remains in the body
• Magnetic Resonance Imaging — The use of magnetic resonance imaging (MRI) among
IPG patients has been contraindicated by MRI manufacturers. Patients who have any
component of the Inspire system implanted should not undergo MRI. MRI can cause
tissue damage as well as damage to the Inspire system and components.
• Sleep remote use — When operating their Inspire sleep remote, patients should use
special care near flammable or explosive atmospheres. An interaction between the
flammable or explosive atmospheres and the battery in the sleep remote could occur. The
consequences of using the battery-powered sleep remote near flammable or explosive
atmospheres are unknown.
• Body Mass Index (BMI) — BMI greater than 32 was not studied as part of the pivotal trial.
Based on data from the feasibility study, it may be associated with decreased likelihood of
response to treatment. Use of Inspire UAS in higher BMI patients is not recommended due
to unknown effectiveness and safety.
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