Abiomed Impella LD Gebrauchsanweisung Seite 14

IMPELLA LD CATHETER PARAMETERS
®
Speed range
Power consumption
Voltage
Flow-Maximum
Purging the Impella LD Catheter
®
Recommended purge fluid
Dextrose concentration
Purge pressure
Purge
Maximum duration of use
EU and Canada
Reliability
Classification per DIN EN 60601-1
Classification per directive 93/42/EEC
Latex free
IMPELLA LD CATHETER DIMENSIONS
®
DISPOSING OF THE IMPELLA LD CATHETER AND ACCESSORIES (EUROPEAN UNION)
The Impella LD Catheter and connector cable are disposable items that must be disposed of in accordance with hospital regulations for blood contaminated
materials.
The Automated Impella Controller is marked according to Directive 2012/19/EU. Devices sold within the EU can be returned to Abiomed Europe
GmbH for correct disposal.
12
0 to 33,000 rpm
Less than 13 W
Max. 20 V DC
5.0 L/min
5% glucose solution with heparin concentration of 50 IU per mL
5% to 20%
300 to 1100 mmHg
2 to 30 mL/hr
Up to 10 days
91.4% with 80% confidence at 10 days based on chi-squared
test
Protection class I, degree of protection:
CF (Automated Impella Controller and Impella LD Catheter)
Class III
Yes
125 cm (min) to 133 cm (max)
9 Fr 21 Fr
10 cm
7 cm
User Manual