Abiomed Impella LD, User Manual

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User Manual
IMPELLA LD
®
CATHETER PARAMETERS
Speed range 0 to 33,000 rpm
Power consumption
Less than 13 W
Voltage
Max. 20 V DC
Flow-Maximum
5.0 L/min
Purging the Impella LD
®
Catheter
Recommended purge fluid
Dextrose concentration
Purge pressure
Purge 5% glucose solution with heparin concentration of 50 IU per mL
5% to 20%
300 to 1100 mmHg
2 to 30 mL/hr
Maximum duration of use
EU and Canada
Reliability Up to 10 days
91.4% with 80% confidence at 10 days based on chi-squared
test
Classification per DIN EN 60601-1 Protection class I, degree of protection:
CF (Automated Impella Controller and Impella LD Catheter)
Classification per directive 93/42/EEC
Class III
Latex free
Yes
IMPELLA LD
®
CATHETER DIMENSIONS
21 Fr 9 Fr
7 cm
10 cm
125 cm (min) to 133 cm (max)
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.
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