Specifications
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Specifications
System Specifications
Models EKOS™ EkoSonic™ Endovascular System consisting of:
(A) EKOS™
Control Unit (Model 4.0)
(1) Power cord
(2) Connector Interface Cable
(B) EkoSonic™
Device (2)
Classification Complies with ISO 60601-1, Edition 3.
Complies with ISO 60601-1-2 Class A Emissions Limits when used
with the provided medical grade power cord, two Connector Interface
Cables (700-10410), and two EkoSonic™ Devices, each consisting
of an Infusion Catheter and a Ultrasonic Core.
Class I, Grounded Equipment
Type CF Patient Applied Parts, Defibrillation proof
Mode of Operation: Continuous, with automatic shut-off features
Control Unit water ingress rating: IPX2
Connector Interface Cable water ingress rating: IPX4
Device Frequency 2.05 – 2.35 MHz
Ultrasound Transducer PZT (Lead Zirconate Titanate)
Composition
System Output Power Automatically controlled, 100W pulse power maximum
70W average device power maximum for both channels (35W
average device power maximum per channel.)
Maximum Device Temperature 43°C Temperature Limit
During normal use, ultrasound therapy may cause a temperature rise
in the treatment zone. There are temperature sensors in the
EkoSonic Device. Control Unit 4.0 monitors the device temperature
and controls power output to limit the device temperature to a
maximum of 43°C. Brief excursions near or above 43 will result in
temporary suspension of ultrasound. The control unit will suspend
therapy and alert the operator if the safety limits of 43°C for 25
seconds or 52°C for 1 second are exceeded.
Power Requirements 100 – 240V, 50/60Hz, 1.6A maximum
Environmental Conditions:
Humidity 30% to 75%, non-condensing
Storage Temperature -20°C to +60°C
Operating Temperature +15°C to +40°C
Operating Atmospheric
Pressure 73 kPa – 111 kPa
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