Impulse Dynamics OPTIMIZER Smart Mini Instructions For Use Manual page 71

3.18.2.2 Posture
The Posture setting controls the use of the built-in accelerometer in the
OPTIMIZER Smart Mini IPG to collect information about the patient's posture
(e.g., lying vs. standing).
To set the Posture:
1. If necessary, initiate a link with OPTIMIZER Smart Mini IPG
2. Tap the Preferences button on the Menu Bar
3. Select the Data Storage tab
4. On the Data Storage panel, tap the Activity Tracking toggle switch to
5. Tap the Posture toggle switch to enable (ON) or disable (OFF) the
6. Tap the blinking Program button on the Programming Buttons Pane to
3.18.2.3 HRV
The HRV setting controls the use of the OPTIMIZER Smart Mini IPG to collect
information about the patient's heart rate variability (HRV). HRV is calculated
using Root Mean Square of Successive Differences (RMSSD).
To set the HRV:
1. If necessary, initiate a link with OPTIMIZER Smart Mini IPG
2. Tap the Preferences button on the Menu Bar
3. Select the Data Storage tab
4. On the Data Storage panel, tap the Activity Tracking toggle switch to
5. Tap the HRV toggle switch to enable (ON) or disable (OFF) the setting
6. Tap the blinking Program button on the Programming Buttons Pane to
3.19 Blinded Mode
Note: The Blinded Mode is to be used only for blinded clinical investigation protocols.
When the OPTIMIZER Smart Mini IPG is used for a blinded clinical investigation, the study
protocol may stipulate that the OPTIMIZER Smart Mini IPG implanted in one group of patients be
programmed not to deliver CCM therapy. Since the battery discharge rate of an OPTIMIZER
Smart Mini IPG programmed to not deliver CCM therapy is significantly less than an OPTIMIZER
Smart Mini IPG programmed to deliver CCM therapy, this disparity in battery discharge rates may
lead to the unblinding of the patient's device configuration.
The blinded mode feature allows the charging behavior of an OPTIMIZER Smart Mini IPG that is
not programmed to deliver CCM therapy to mimic the behavior of an OPTIMIZER Smart Mini IPG
that is programmed to deliver CCM therapy.
a. Place (or replace, if necessary) the Intelio Programming Wand over
the OPTIMIZER Smart Mini IPG implant site
b. Tap the Start OPTIlink button on the OPTIlink Session Pane
enable (ON)
setting
load the OPTIMIZER Smart Mini IPG with the new parameter setting
a. Place (or replace, if necessary) the Intelio Programming Wand over
the OPTIMIZER Smart Mini IPG implant site
b. Tap the Start OPTIlink button on the OPTIlink Session Pane
enable (ON)
load the OPTIMIZER Smart Mini IPG with the new parameter setting
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