Use Instructions

5.6 Therapeutic Ultrasound

Warning: Direct exposure of the OPTIMIZER Smart Mini IPG to therapeutic ultrasound can

damage the device. In addition, the OPTIMIZER Smart Mini IPG can inadvertently

concentrate the ultrasound field and cause harm to the patient.

Therapeutic ultrasound can be used provided the implant is located far away from the ultrasound

field. Precautionary programming of the OPTIMIZER Smart Mini IPG to OOO mode reduces the

risk of adverse effects. The patient’s peripheral pulse should be monitored during the procedure.

Immediately after the treatment, the OPTIMIZER Smart Mini IPG should be checked for proper

function. If the device is found to have reverted to its “DOWN” mode, it needs to be reset.

5.7 Nuclear Magnetic Resonance (NMR), Magnetic Resonance Imaging

(MRI)

Warning: Patients with an implanted OPTIMIZER Smart Mini IPG should not be exposed to NMR

or MRI.

Exposure of the OPTIMIZER Smart Mini system to strong magnetic and electromagnetic fields

encountered within MRI systems has not been investigated. Even though programming the IPG

into Standby (OOO) mode reduces the risk of adverse events, exposure of the patient to an MRI

scan could result in the following:

• Unintended cardiac stimulation (induced tachycardia)

• Tissue damage near the IPG and lead electrodes with the result of inability to deliver

CCM therapy

• Device malfunction (discharge of battery, damage to device electronics, reverted to its

“DOWN” mode)

If the device is found to have reverted to its “DOWN” mode, it will need to be reset, which will

clear the statistical data stored in the device.

5.8 Radiation Therapy

Warning: Therapeutic equipment generating ionizing radiation, such as linear accelerators and

cobalt machines employed for treating malignant diseases, can damage the circuits

used in most active implantable devices. Because the effect is cumulative, both dose

rate and total dose determine if damage will occur and its possible extent. Be aware

that certain types of damage might not be immediately detectable. In addition, the

electromagnetic fields generated by some types of radiation equipment for beam

“steering” purposes can affect the function of the OPTIMIZER Smart Mini IPG.

Radiation therapy can lead to a wide spectrum of effects, reaching from transient interference to

permanent damage. It is therefore advisable to locally shield the OPTIMIZER Smart Mini IPG

against radiation if radiation therapy is to be used. During a radiation treatment and thereafter, the

function of the IPG needs to be monitored. If tissue in the vicinity of the implant has to be

irradiated, it may be advisable to relocate the OPTIMIZER Smart Mini IPG.

5.9 Lithotripsy

Warning: Direct exposure of the OPTIMIZER Smart Mini IPG to shock waves can damage the

device. A device implanted outside the shock wave path presents no clear-cut

contraindication to lithotripsy. Precautionary programming of the OPTIMIZER Smart

Mini IPG to OOO mode reduces the risk of adverse effects. The patient’s peripheral

pulse should be monitored during the procedure. Immediately after the treatment, the

OPTIMIZER Smart Mini IPG should to be checked for proper function. If the device is

found to have reverted to its “DOWN” mode, it will need to be reset by qualified

personnel. A consequence of a device reset is that all statistical data stored in the IPG

is cleared.