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Acessa
ProVu System User's Guide
®
Compliance to Safety and Performance Standards
18.4.
The Acessa ProVu System has been tested to the following standards:
Reference Number
ISO 14971:2007
EU Directive 93/42/EEC Medical Devices Directive (MDD)
ASTM D4169-16
IEC 60601-1 Ed. 3.1
IEC 60601-1-2 Ed. 4.0
IEC 60601-2-2 Ed
5.0:2017
IEC 62304 Ed. 1.1
IEC 60529 Ed 2.2:2015
ISO 13485: Ed 3:2016
19. Trouble Shooting
Faults, Alerts, and Errors
19.1.
•
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
Tip of Ultrasound Transducer is near the
edge of the field.
Tip of Handpiece shaft is near the edge
of the field.
Handpiece is out of the tracking field.
Ultrasound transducer is out of the
tracking field.
Metal has been detected in the tracking
field.
The software is experiencing poor-
quality tracking
Handpiece sensor signal is lost
CO 20-131 Revision: C
Title
Medical devices – Application of risk management to medical devices (ISO 14971:2007,
Corrected version 2007-10-01)
Standard Practice for Performance Testing of Shipping Containers and Systems
Medical electrical equipment - Part 1: General requirements for basic safety and essential
performance
Medical electrical equipment - Part 1-2: General requirements for basic safety and
essential performance - Collateral standard: Electromagnetic compatibility - Requirements
and tests
Medical electrical equipment - Part 2-2: Particular requirements for basic safety and
essential performance of endoscopic equipment
Medical Device Software – Software Life Cycle Processes
Degrees of Protection Provided by Enclosures (IP Code)
Medical devices -- Quality management systems -- Requirements for regulatory purposes
Visual Alert
"UT near edge of field"
"Handpiece near edge of field"
"Handpiece out of field"
"UT out of field"
"Remove metal or interference"
"Bad Tracking"
"Handpiece tracking signal lost"
Audible
Solution
Alert
No
Continue the procedure.
No
Continue the procedure.
No
Move the handpiece into the field
No
Move the transducer into the field
No
Remove metal from the field
No
Monitor the tracking
No
1. Check Handpiece or cable
connection
2. If connections are good, replace
Cable.
3. If Cable was good, replace
Handpiece.
PL-01-0040
36
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