16
Table 5: Alarms Condition, Display, LED status, and Audio Alarm output level.
Alarm Condition
Display
LED Audio Alarm
Max. ICP Exceeded
Flashing “HI” text to left of ICP average
Y
Medium
Min. ICP Exceeded
Flashing “LO” text to left of ICP average
Y
Medium
In Package Check Failure
“Sensor Check Failure”
N
None
Monitor Over Temperature
“Monitor Cooling”
N
Medium
Battery Temperature High
Screen 1: “Battery Temp High”
Screen 2:
“Change Battery, Check Manual”
N
Medium
Low Battery
Screen 1: “Battery Low”
Screen 2: “Change Battery”
N
Medium
Critically Low Battery
Screen 1: “Battery CRITICAL”
Screen 2: “Change Battery”
N
Medium
Receiver Not Calibrated
Screen 1: “Receiver Not
Calibrated
”
Screen 2: “Calibrate Receiver”
N
Low
Receiver Issue
Screen 1: “Receiver Error”
Screen 2: “Connect Receiver”
N
Low
10.
COMPLIANCE STATEMENTS
EMI/RFI
This equipment has been tested and found to comply with the applicable limits
for medical devices, IEC 60601-1-2:2007.
Although this testing shows the device to provide reasonable protection against
harmful interference in a typical medical installation, there is no guarantee that
interference will not occur in a particular installation. If the device does cause
harmful interference the user is encouraged to try and correct the interference
by the following measures:
•
Reorient or relocate the device
•
Increase the separation between the devices
•
Connect the equipment to an outlet on a different circuit
•
Contact Branchpoint Technologies using the information on the back cover
of this manual
NOTE:
“Harmful interference” is defined by the FCC as follows:
Any emission, radiation or induction that endangers the functioning
of a radio navigation service or of other safety services or seriously
degrades, obstructs or repeatedly interrupts a radio
communications service operating in accordance with FCC rules.
ESSENTIAL PERFORMANCE
Essential performance is maintained as long as the AURA
TM
ICP Monitoring
System can be brought back into a functional state to measure and display ICP
to the user without requiring surgical intervention to remove or replace the
sensor.
The performance limit for ICP measurement accuracy is ± 2 mmHg for ICP
values of 0 to 20 mmHg, and ± 10% for ICP values above 20 mmHg during
normal and single fault conditions.
