Abiomed Impella LD Gebrauchsanweisung Seite 24

22
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
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.
5.0 L/min
5% dextrose solution with heparin concentration of 50 IU per
mL
5% to 40%
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
Class III
Yes
125 cm (min) to 133 cm (max)
9 Fr
LD CATHETER AND
®
® LD Catheter)
10 cm
7 cm
21 Fr
User Manual