Impulse Dymanics OPTIMIZER Smart System - User Profile and Training

5
These are for the following conditions:
• Number of pulses per CCM train: 2
• Phase duration: 5.14 ms
• Heart rate: 85 bpm
Under these conditions, the average current drain from the battery during CCM delivery
is approximately as follows:
VBAT (V) Impedance (OHM)
Stimulation
amplitude (V)
Average Measured
Current Drain
(uA)
3.4
220
5
1,420
3.4
220
7
2,603
3.4
300
5
1,094
3.4
300
7
1,848
3.4
600
5
613
3.4
600
7
1,015
3.4
900
5
468
3.4
900
7
734
3.4
1200
5
412
3.4
1200
7
596
4.1
220
5
1,159
4.1
220
7
2,124
4.1
300
5
909
4.1
300
7
1,652
4.1
600
5
511
4.1
600
7
879
4.1
900
5
402
4.1
900
7
652
4.1
1200
5
394
4.1
1200
7
582
Failure to recharge the OPTIMIZER Smart IPG in a timely manner may cause the device
to revert to Standby (OOO) mode and to suspend CCM signal delivery. In this mode, the
device has to be recharged first before it resumes therapy delivery.
1.8 User Profile and Training
The operators of the OPTIMIZER Smart System include patients, physicians (and trained
medical personnel who assist them) and Impulse Dynamics Representatives. Physicians,
medical personnel and Company representatives shall be familiar with operation of
electronic medical equipment, particularly IPGs, and programmers.
Physicians and medical personnel will have participated in a Company-sponsored
training program which will provide both theoretical and hands on training regarding the
technology, device features and detailed operating instruction for the IPG, the
programmer, and patient charger. The need for future retraining regarding the
OPTIMIZER Smart System is determined by Company personnel based on the user’s
individual implant history and frequency.