Specifications; Electronic And Electromagnetic Guidance - Boston Scientific AngioJet Ultra 5000A Console Manual Del Usuario

Check Saline Supply Alarm: A recoverable condition occurring when an abnormally
low pressure has been detected. Replacement of the Thrombectomy Set may
be necessary.
Collection Bag: The bag which collects the extracted thrombus being removed by the
catheter. The bag hangs on the Console drawer.
Control Panel: The operator interface on the upper front of the Console.
Error: A nonrecoverable fault which has occurred because of Thrombectomy Set or
Console malfunction.
Saline Delivery Tubing: The tubing which transports saline from the saline bag to
the pump.
Self-Test: An operation performed by the Console to examine the fidelity and the state
of its circuit paths and sensors. An appropriate indicator will be illuminated if any
abnormality is detected.
Thrombectomy Set: The disposable component of the AngioJet™ Thrombectomy
System which delivers pressurized saline and removes debris. It consists of the saline
bag spike, saline delivery tubing, pump, catheter, waste tubing, and collection bag.
Waste Tubing: The tubing which is inserted in the roller pump and transports the
extracted thrombus from the effluent tubing to the collection bag.

SPECIFICATIONS

Model Number
Dimensions, D x W x H
Weight
Voltage requirements
Frequency requirements
Power requirements
Logic power backup outage
Equipment class
Degree of protection against
electrical shock
Enclosure protection against ingress
of liquid
Foot switch protection against
ingress of liquid
Mode of (electrical) operation
Transport temperature
Transport relative humidity
Transport atmospheric pressure
Storage temperature
Storage relative humidity
Storage atmospheric pressure
Operation temperature
Operation Humidity
Operation atmospheric pressure
Pollution
Installation/Overvoltage
Fuse
Cables
The AngioJet Ultra Console is UL LLC Classified to
ANSI/AAMI ES60601-1:A1:2012, C1:2009/(R)2012 and A2:2010/(R)2012,
CSA CAN/CSA-C22.2 No. 60601-1:14; UL 60601-1, CAN/CSA C22.2 No. 601.1.
Note: If it becomes necessary to replace the fuse, replace fuse with the type and
rating specified. Failure to do so may result in device damage or risk of fire.
5000A
25 in x 16.5 in x 54 in
(63.5 cm x 42 cm x 137 cm)
140 lbs (63.5 kg)
100/120/220/240 VAC
50/60 Hz
900 VA
60 seconds for conditions of power loss
Class 1
Defibrillation-Proof Type CF Applied Part
IPX 1
IPX 8
Continuous
-25 °C to 55 °C (-13 °F to 131 °F)
10% to 95% (noncondensing)
500 hPa to 1060 hPa
-25 °C to 55 °C (-13 °F to 131 °F)
10% to 95% (noncondensing)
500 hPa to 1060 hPa
10 °C to 40 °C (50 °F to 104 °F)
30% to 75% (noncondensing)
700 hPa to 1060 hPa
No greater than degree 2
No greater than category 2
100/120V, T10AL, 250V, 5 mm x 20 mm
220/240V, T6.3AL, 250V, 5 mm x 20 mm
AC adapter cable
Maximum Cord Length 10 ft (3.05 m)
Foot Switch
Maximum Cord Length 15 ft (4.57 m)

ELECTRONIC AND ELECTROMAGNETIC GUIDANCE

Table 1� Guidance and manufacturer's declaration – electromagnetic emissions
The AngioJet System is intended for use in the electromagnetic environment specified
below. The customer or the user of the AngioJet System should assure that it is used in
such an environment.
Emissions Test Compliance
RF emissions
Group 1
CISPR 11
RF emissions
Class A
CISPR 11
Harmonic emissions
Class A
IEC 61000-3-2
Voltage fluctuations flicker/
emissions Complies
IEC 61000-3-3
NOTE: The emissions characteristics of this equipment make it suitable for use
in industrial areas and hospitals (CISPR 11 class A). If it is used in a residential
environment (for which CISPR 11 class B is normally required) this equipment
might not offer adequate protection to radio-frequency communication services.
The user might need to take mitigation measures, such as relocating or
re-orienting the equipment.
11
Electromagnetic Environment –
Guidance
The AngioJet System uses
RF energy only for its internal
function. Therefore, its RF
emissions are very low and
are not likely to cause any
interference in nearby electronic
equipment.
The AngioJet System is suitable
for use in all establishments
other than domestic and those
directly connected to the public
low-voltage power supply
network that supplies buildings
used for domestic purposes.
Black (K) ∆E ≤5.0