Compliance Statements; Essential Performance - Branchpoint Technologies AURA TK101-A Instructions For Use Manual

Table 5: Alarms Condition, Display, LED status, and Audio Alarm output level.
Alarm Condition
Max. ICP Exceeded
Min. ICP Exceeded
In Package Check Failure
Monitor Over Temperature
Battery Temperature High
Low Battery
Critically Low Battery
Receiver Not Calibrated
Receiver Issue

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
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.
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Display
Flashing "HI" text to left of ICP average
Flashing "LO" text to left of ICP average
"Sensor Check Failure"
"Monitor Cooling"
Screen 1: "Battery Temp High"
Screen 2: "Change Battery, Check Manual"
Screen 1: "Battery Low"
Screen 2: "Change Battery"
Screen 1: "Battery CRITICAL"
Screen 2: "Change Battery"
Screen 1: "Receiver Not Calibrated"
Screen 2: "Calibrate Receiver"
Screen 1: "Receiver Error"
Screen 2: "Connect Receiver"
LED Audio Alarm
Y Medium
Y Medium
N None
N Medium
N Medium
N Medium
N Medium
N Low
N Low
ICP Monitoring
TM