User's Manual

15
CPR4 – UA10821A
This equipment complies with FCC radiation exposure limits set forth for an uncontrolled environment and meets the
FCC radio frequency (RF) Exposure Guidelines.
This equipment has very low levels of RF energy that is deemed to comply without testing of specific absorption
rate(SAR).
8.3 Performances
8.3.1 PERFORMANCE CHARACTERISTICS
The table below describes the performance characteristics of the programmer (including programming software)
making use of a CPR4.
Performance
Value
Interrogation time
Less than 60 seconds
AIDA reading time
No more than 180 seconds
Number of telemetry issues
No more than 5 errors per minute
Number of telemetry errors pop-ups
No more than 1 pop-up per session
8.3.2 ESSENTIAL PERFORMANCE (REFERRING TO 60601-1-2 STANDARD)
The essential performance of the CPR4 is to ensure data integrity when it reads data from the MicroPort implantable
device and when it programs data in the implantable device. Should the CPR4 essential performance deteriorate, it
could induce an inappropriate clinical or medical treatment (wrong interpretation of data read or misprogramming).
8.4 Dimensions
Height
136 mm
Width
73 mm
Depth
23.5 mm
Weight
0.300 kg
8.5 Use constraints
Temperature
From +0 °C to +35 °C (non-condensing)
Humidity
From 5% to 95 % HR (non-condensing)
Pressure
From 700 to 1060 hPa
8.6 Storage constraints
Temperature
From -20 °C to +70 °C (non-condensing)
Humidity
From 5% to 95% HR (non-condensing)
Atmospheric pressure
From 500 hPa to 1060 hPa
9 EXPLANATION OF SYMBOLS
General symbols
Explanation of symbols
This symbol concerns the inductive programming head. It indicates that this is a BF
Type applied part, according to standard IEC 60601-1 for electrical medical
equipment.