Acessa
®
ProVu System User’s Guide
PL-01-0040
CO 20-131 Revision: C
36
18.4.
Compliance to Safety and Performance Standards
The Acessa ProVu System has been tested to the following standards:
Reference Number
Title
ISO 14971:2007
Medical devices – Application of risk management to medical devices (ISO 14971:2007,
Corrected version 2007-10-01)
EU Directive 93/42/EEC Medical Devices Directive (MDD)
ASTM D4169-16
Standard Practice for Performance Testing of Shipping Containers and Systems
IEC 60601-1 Ed. 3.1
Medical electrical equipment - Part 1: General requirements for basic safety and essential
performance
IEC 60601-1-2 Ed. 4.0
Medical electrical equipment - Part 1-2: General requirements for basic safety and
essential performance - Collateral standard: Electromagnetic compatibility - Requirements
and tests
IEC 60601-2-2 Ed
5.0:2017
Medical electrical equipment - Part 2-2: Particular requirements for basic safety and
essential performance of endoscopic equipment
IEC 62304 Ed. 1.1
Medical Device Software – Software Life Cycle Processes
IEC 60529 Ed 2.2:2015 Degrees of Protection Provided by Enclosures (IP Code)
ISO 13485: Ed 3:2016
Medical devices -- Quality management systems -- Requirements for regulatory purposes
19.
Trouble Shooting
19.1.
Faults, Alerts, and Errors
•
The system detects and displays fault and error conditions.
•
A fault is a correctible condition that produces an Alert screen while an error is irreversible and requires system
reboot to clear.
•
When a fault occurs with RF on, RF is automatically turned off with audible and visual alerts provided. The user
will be required to press the “Check” button to acknowledge the alert.
•
When a fault occurs with RF off, it is indicated by a visual alert only.
•
If the system components that provide Guidance fail, the display will revert to displaying the Ultrasound screen
only.
19.2.
Fault/Alert Code Table
Condition
Visual Alert
Audible
Alert
Solution
Tip of Ultrasound Transducer is near the
edge of the field.
“UT near edge of field”
No
Continue the procedure.
Tip of Handpiece shaft is near the edge
of the field.
“Handpiece near edge of field”
No
Continue the procedure.
Handpiece is out of the tracking field.
“Handpiece out of field”
No
Move the handpiece into the field
Ultrasound transducer is out of the
tracking field.
“UT out of field”
No
Move the transducer into the field
Metal has been detected in the tracking
field.
“Remove metal or interference” No
Remove metal from the field
The software is experiencing poor-
quality tracking
“Bad Tracking”
No
Monitor the tracking
Handpiece sensor signal is lost
"Handpiece tracking signal lost" No
1. Check Handpiece or cable
connection
2. If connections are good, replace
Cable.
3. If Cable was good, replace
Handpiece.
