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
21
Expected Service Life
The EKOS Control Unit 4�0 Control System is self-diagnostic and provides user feedback on its functional status� Refer to the
Troubleshooting Section�
The Expected Service life of the Control System 4�0 is five (5) years; however, it may continue to be used beyond that time period if its self-
diagnostic functions report no issue with its performance�
The internal battery is intended to provide at least 15 minutes of therapy on two channels, 30 minutes of therapy on a single channel and at
least 2 hours of operation when no therapy is running for at least two years of service� If you find the battery is discharging quickly, contact
Boston Scientific to arrange a battery replacement� Note that battery maintenance may be needed every two years�
Warning:
Do not disassemble or modify the Control Unit or CIC� There are no customer serviceable parts� Only the manufacturer or Boston
Scientific authorized personnel should service the Control Unit and CIC� Improper disassembly of the Control Unit could result in electric
shock or burn�
Ultrasound Operation
Warning:
The Control Unit is designed for use with the EKOS Device, approved cables and electronic devices� Do not connect non-
EKOS devices, cables (e�g�, power cord) or electronic equipment to the Control Unit� Use of non-approved devices, cables and electronic
equipment could result in electric shock or burn, increased electromagnetic interference (EMI) emissions, decreased immunity to EMI from
other sources, or delay of therapy�
Warning:
Inspect all connectors, cables and the Control Unit for damage prior to use� If damaged (e�g�, exposed wires), do not use and
replace immediately�
Warning:
Ensure all connectors are dry before connecting the Connector Interface Cable to the Control Unit or the Connector Interface Cable
to the EKOS Device� If connectors do become wet, thoroughly dry prior to use� Fluid in the connectors may affect sensor accuracy and result
in vascular injury�
Warning:
Connect system cables only to their proper connectors as marked and ensure connections are secure� Failure to do so could result
in electric shock or burn�
Warning:
Avoid spilling fluids on the cables and Control Unit� Do not immerse any portion of the cables or Control Unit in water or other
fluids as this may cause the equipment to perform inaccurately or fail, which could result in vascular injury, electric shock or fire�
Precaution:
When using two EKOS Devices (one in channel A and one in channel B), care should be taken to ensure that desired actions (e�g�,
start ultrasound, stop ultrasound, connect cables, disconnect cables, respond to an alert message) are performed on the correct channel(s)
or device(s)�
Precaution:
When using two EKOS Devices (one in channel A and one in channel B), care should be taken to not cross the device cables�
Ensure each pair of device cables is connected to a single Connector Interface Cable� If the device cables are crossed, ultrasound is not
operational and could result in delay of ultrasound therapy�
System Configurations
This section describes how to select audible alert tone volume, screen brightness and language on the Control Unit�
Precaution:
When using the Control Unit, care should be taken to optimize the display brightness and volume level for the use environment�
Failure to optimize could cause audible and visual information being missed resulting in delay of ultrasound therapy�
To access the system settings, press the Settings tab on the display (see Figure 7)�
