Abiomed Impella 5.0 Gebrauchsanweisung Seite 22

Latex Free
The Automated Impella ®
Controller and Impella ® 5.0
Catheter, including all accessories,
are latex free.
20
WHITE CONNECTOR CABLE
Length
Service life
IMPELLA 5.0 CATHETER PARAMETERS
®
Speed range
Power consumption
Voltage
Flow-Maximum
Purging the Impella 5.0 Catheter
®
Recommended purge fluid
Dextrose concentration
Purge pressure
Purge flow
Maximum duration of use
EU and Canada
Reliability
Dimensions of Impella 5.0 Catheter
®
Length of invasive portion (without catheter)
Diameter
Classification per DIN EN 60601-1
Classification per directive 93/42/EEC
Latex free
IMPELLA 5.0 CATHETER DIMENSIONS
®
43-45 cm
Length of
sterile sleeve
2.5 m
Single use only
0 to 33,000 rpm
Less than 1.07 W
Max. 18 V DC
5.0 L/min
5% dextrose solution with heparin concentration of 50 IU
per mL
5% to 40%
300 to 1100 mmHg
0 to 20 mL/hr
Up to 10 days
91.4% with 80% confidence at 10 days based on chi-squared
test
140 ± 3 mm
Max. 7.2 mm (nom. 7.0 mm)
Protection class I, degree of protection:
CF (Automated Impella Controller and Impella
®
Catheter)
Class III
Yes
6 Fr
9 Fr 21 Fr
10 cm
Repositioning
sheath
117 cm (min) to 125 cm (max)
Differential
pressure
sensor
3.5 cm
8 cm
11.5 cm
14 cm
5.0
®
User Manual