Maintenance; Routine Maintenance; Planned Maintenance Program; User Routine Checks Program - Profound Sonalleve MR-HIFU Instructions For Use Manual

7. Maintenance > 7.1. Routine maintenance

7.1. Routine maintenance

This product requires proper operation, routine checks and planned maintenance, to keep the
product operating safely, effectively, and reliably.

7.1.1. Planned Maintenance Program

Planned maintenance may only be carried out by qualified and authorized personnel, and is
comprehensively described in the service documentation. Profound Medical provides a full planned
maintenance and repair service on both a call basis and a contract basis. Full details are available
from your Profound Medical service organization.

7.1.2. User Routine Checks Program

The user of the product must institute a User Routine Checks Program as detailed in the table
below. The user of the product shall ensure that all checks and actions have been satisfactorily
completed before using the product for its intended purpose.
Tab. 24: User Routine Checks Program.
Check
Check that there are no visible leaks from the Sonalleve Table
Top
Quality Assurance procedure with the QA phantom
Visually check that the cables, hoses, connectors and sockets are
undamaged
Check that there are no visible cracks or other defects in the
ultrasound window
Test that the PESB works
Check that the water level in DISC is correct: read the gauge on
DISCfill
Check that there are no large air bubbles visible through the DISC
patient contact
Check that the water level in DISC is correct: the surface of the
patient contact should be flat
Check that there are no obvious leaks from DISC
Instructions for Use
109745C2 / 02-2022

7. Maintenance

Frequency
Daily Before every
procedure
✓
✓
✓
✓
✓
✓
✓
✓
✓
130 (192)