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Bost
on Scientific (Mast
er Br
and,
Spir
al Bound Manual T
empla
te
, 8
.5in x 11in Global,
923100
58G),
IFU
, MB,
CU4,
en,
5
1011236
-001A
Black (K) ∆E ≤5.0
Black (K) ∆E ≤5.0
37
Figure 33. Logo Screen (Shutting Down)
Precaution:
After each use, the Control Unit should be plugged into a hospital-grade outlet to ensure the battery is recharged fully� Failure
to plug in the AC power after use could result in the battery not being fully charged and delay of ultrasound therapy�
5� The Connector Interface Cable may be stored on the side of the Control Unit (see Figure 4)� It is not recommended that the Connector
Interface Cable be placed on the side of the Control Unit during ultrasound therapy because the cord lengths are restricted�
6� See Maintaining the Control Unit section for instructions on cleaning and storing the Control Unit�
Any serious incident that occurs in relation to this device should be reported to the manufacturer and relevant local regulatory authority�
INFORMATION TO BRIEF THE PATIENT
The physician should consider the following points while counseling the patient on the use of the EKOS Endovascular System in association
with the interventional procedure:
• Discuss the risks and benefits, including review of potential adverse events listed in the EKOS Device IFU, both for EKOS Endovascular
System and for other interventional treatments likely to be employed�
• Discuss post-procedure instructions, including any lifestyle changes, medications, and home care and rehabilitation guidelines�
No separate patient information is provided because the EKOS Endovascular System is used in association with other interventional
procedures� Risks and benefits to the patient are similar to and, from the patient’s perspective, a part of those interventional procedures�
SYSTEM INFORMATION
This section describes how to view information for the Control Unit, the Connector Interface Cable and the EKOS Device�
To access the system information, press the
Information
tab on the display (see Figure 34)�
Figure 34. System Information Screen
/CMYK