Use Instructions

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If a TENS unit is used nonetheless, the TENS electrodes should be attached as far as possible
from the OPTIMIZER Smart Mini IPG and its leads. In addition, aiming for a limited current path,
consider placing the TENS electrodes as close to each other as possible. The patient’s peripheral
pulse should be closely monitored while TENS is applied. Precautionary programming the
OPTIMIZER Smart Mini IPG to OOO mode reduces the risk of adverse effects.
6.3 Home Appliances
Home and commercial microwave ovens do not affect the operation of the OPTIMIZER Smart
Mini IPG, provided they are in good condition and used as intended. Even microwave energy
from a severely defective microwave oven directly radiating onto the IPG does not damage the
device, although the sensing function may be impaired, which could eventually impact CCM
therapy delivery.
However, patients with an implanted OPTIMIZER Smart Mini IPG should be advised not to use or
come in close proximity to induction stoves as they could cause interference.
Patients with an implanted OPTIMIZER Smart Mini IPG should be advised that some electric
razors, electric power tools, and electric ignition systems, including those of gasoline powered
engines, could cause interference. Generally, patients implanted with an OPTIMIZER Smart Mini
IPG may use gasoline powered engines, provided that protective hoods, shrouds, and other
shielding devices have not been removed.
6.4 Store Anti-Theft Systems/Airport Security Screening Systems
Certain types of anti-theft systems, such as those installed at entrances/exits of stores, libraries
and other facilities, as well as airport security systems can interfere with the OPTIMIZER Smart
Mini IPG. Such interference would most often inhibit CCM therapy delivery. Patients should be
advised to walk through such systems at a normal pace, i.e. not to slow down while passing
through. Prior to passing through airport security systems, patients should notify the attendant
security personnel that they carry an implant and should present their implant ID card.
6.5 Industrial Machinery
High voltage power lines, electric and arc welders, electric smelters, and power-generating
equipment can interfere with the operation of the OPTIMIZER Smart Mini IPG. For that reason,
one needs to take into account the field strengths and modulation characteristics of all
electromagnetic fields patients are exposed to in their workplaces or due to their lifestyle. Patients
need to be specifically warned about these risks, or the OPTIMIZER Smart Mini IPG should be
programmed to minimize its susceptibility.
6.6 Transmitting Devices
Communication equipment such as radio and TV transmitters (including amateur [“ham radio”]
transmitters, microwave radio, and CB radio transmitters with power amplifiers) as well as radar
transmitters can interfere with the operation of the OPTIMIZER Smart Mini IPG. For that reason,
one needs to take into account the field strengths and modulation characteristics of all
electromagnetic fields patients are exposed to in their workplaces or due to their lifestyle. Patients
need to be specifically warned about these risks, or the OPTIMIZER Smart Mini IPG should be
programmed to minimize its susceptibility.
6.7 Cellular and Mobile Phones
Cell phones and other mobile phones can affect the operation of the OPTIMIZER Smart Mini IPG.
These effects can be caused by the radio frequencies emitted by the phones or by the phones’
speaker magnets. Potential effects include inhibition of or inappropriate CCM therapy delivery if
the phone is in very close proximity (within 10 in) of an OPTIMIZER Smart Mini IPG and the
corresponding leads. Because of the great variety of mobile phones as well as the significant
physiologic differences between patients, it is impossible make generally applicable
recommendations.