User's Manual

Elevated Pressures
The International Standards Organization (ISO) has not approved a standardized pressure test for implantable
pulse generators that experience hyperbaric oxygen therapy (HBOT) or SCUBA diving. However, Boston
Scientific developed a test protocol to evaluate device performance upon exposure to elevated atmospheric
pressures. Th e following summary of pressure testing should not be viewed as and is not an endorsement of
HBOT or SCUBA diving.
CAUTION: Elevated pressures due to HBOT or SCUBA diving may damage the pulse generator. During
laboratory testing, all pulse generators in the test sample functioned as designed when exposed to more than
1000 cycles at a pressure up to 5.0 ATA. Laboratory testing did not characterize the impact of elevated pressure
on pulse generator performance or physiological response while implanted in a human body.
Pressure for each test cycle began at ambient/room pressure, increased to a high pressure level, and then
returned to ambient pressure. Although dwell time (the amount of time under elevated pressure) may have an
impact on human physiology, testing indicated it did not impact pulse generator performance. Pressure value
equivalencies are provided below (Table 1 on page 24).
Table 1. Pressure Value Equivalencies
Pressure value equivalencies
Atmospheres Absolute 5.0 ATA
Sea water depth
a
40 m (130 f t)
Pressure, absolute 72.8 psia
Pressure, gauge
b
58.1 psig
24