Appendix E: Clinical Study Summary - Integra Codman VPV System Manual

2. Press the "30" key to set the next adjustment cycle for an inverted valve, or press "40" to exit. When you press
"30," the display changes to:
3. To confirm that the next adjustment cycle is for an inverted valve, press "80"; or press "40" to cancel and exit.
When you press "80," the display changes to:
Proceed as usual, following the steps in Valve Adjustment: Implanted Valve Mode. At the end of the adjustment cycle, the
program unit returns to the normal adjustment cycle.

Appendix E: Clinical Study Summary

In a clinical study consisting of 172 subjects, 159 subjects had an x-ray taken with a blinded core lab consensus reading.
In these 159 subjects, 103 (65%) of the subjects received an "Adjustment Complete" message and 56 (35%) of the
subjects received a "Repeat Adjustment" message. Of the "Adjustment Complete" patients, 55% received an "Adjustment
Complete" message after the first attempt at reprogramming and 99% received the "Adjustment Complete" message
within the 5 attempts established in the study design.
Table 1 – Guidance and Manufacturer's Declaration – Emissions
All ME Equipment and ME Systems
Guidance and Manufacturer's Declaration - Emissions
The VPV Programmer is intended for use in the electromagnetic environment specified below. The customer or user of
the VPV Programmer should ensure that it is used in such an environment.
Emissions Test Compliance Electromagnetic Environment – Guidance
RF Emissions Group 1 The VPV Programmer uses RF energy only for its internal function. Therefore,
CISPR 11 its RF emissions are very low and are not likely to cause any interference in
nearby electronic equipment.
RF Emissions Class A
CISPR 11
Harmonics Class A
IEC 61000-3-2
Flicker Complies
IEC 61000-3-3
The VPV Programmer is suitable for use in all establishments, other than
domestic, and those directly connected to the public low-voltage power supply
network that supplies buildings used for domestic purposes.
ADJUST INVERTED
VALVE?
PLEASE CONFIRM
80 = YES 40 = NO
IMPLANTED VALVE
INVERTED VALVE
PLEASE SELECT
PRESSURE
Table 2 – Guidance and Manufacturer's Declaration – Immunity
All ME Equipment and ME Systems
Guidance and Manufacturer's Declaration - Immunity
The VPV Programmer is intended for use in the electromagnetic environment specified below. The customer or user of
the VPV Programmer should ensure that it is used in such an environment.
Immunity Test IEC 60601
Test Level
ESD +/-8kV contact
IEC 61000-4-2
+/-2 kV, +/- 4 kV,
+/- 8 kV, - +/- 15 kV air
EFT +/-2kV Mains +/-1kV
IEC 61000-4-4 I/Os
Surge +/-1kV Differential
IEC 61000-4-5 +/-2kV Common
Voltage Dips/ 0 % UT; 0,5 cycle Út
Dropout 0°, 45°, 90°, 135°, 180°,
IEC 61000-4-11 225°, 270° and 315°
0% UT; 1 cycle at 0°×0
% UT; 25/30 cycles 0°
0% UT; for 5 seconds
Power Frequency 30A/m
50/60Hz
Magnetic Field
IEC 61000-4-8
11
Compliance Electromagnetic
Level Environment – Guidance
+/- 8 kV contact Floors should be wood, concrete or
ceramic tile. If floors are synthetic,
+/- 2 kV, +/- 4 kV,
the r/h should be at least 30%
+/- 8 kV, - +/- 15 kV air
+/-2kV Mains +/-1kV Mains power quality should be that
I/Os of a typical commercial or hospital
environment.
+/-1kV Differential Mains power quality should be that
+/-2kV Common of a typical commercial or hospital
environment.
0 % UT; 0,5 cycle Út Mains power quality should be that
0°, 45°, 90°, 135°, 180°, of a typical commercial or hospital
225°, 270° and 315° environment. If the user of the VPV
Programmer requires continued
0% UT; 1 cycle at 0°×0
operation during power mains
% UT; 25/30 cycles 0°
interruptions, it is recommended that the
0% UT; for 5 seconds VPV Programmer be powered from an
uninterruptible power supply or battery.
30A/m Power frequency magnetic fields
should be that of a typical commercial
or hospital environment.
EN – ENGLISH