Abiomed Impella 2.5, Instructions For Use Manual

Page: 196 / 211

9.13 Impella
®
System for Use During Cardiogenic Shock
WHITE CONNECTOR CABLE
Length
2.5 m
Service life
Single use only
IMPELLA
®
CATHETER PARAMETERS
Table 9.11 Impella Catheter Parameters
Impella
®
2.5 Impella CP
®
Impella
®
5.0 Impella
®
LD
Speed range 0 to 51,000 rpm 0 to 46,000 rpm 0 to 33,000 rpm 0 to 33,000 rpm
Power consumption 19.8 W 24 W Less than 13 W Less than 13 W
Voltage Max. 20 V DC Max. 20 V DC Max. 20 V DC Max. 20 V DC
Flow-Maximum 2.5 L/min 3.3 L/min 5.0 L/min 5.0 L/min
Purging the Impella
®
Catheter
Recommended purge fluid
Dextrose concentration
Purge pressure
Infusion rate
20% dextrose
solution with heparin
concentration of 50 IU
per mL
5% to 40%
300 to 1100 mmHg
2 to 30 mL/hr
20% dextrose
solution with heparin
concentration of 50 IU
per mL
5% to 40%
300 to 1100 mmHg
2 to 30 mL/hr
20% dextrose
solution with heparin
concentration of 50 IU
per mL
5% to 40%
300 to 1100 mmHg
2 to 30 mL/hr
20% dextrose
solution with heparin
concentration of 50 IU
per mL
5% to 40%
300 to 1100 mmHg
2 to 30 mL/hr
Catheter dimensions
Length of invasive portion
(without catheter)
Diameter
130 ± 3 mm
Max. 4.2 mm (nom.
4.0 mm)
150 ± 3 mm
Max. 4.9 mm (nom.
4.7 mm)
155 ± 3 mm
Max. 7.2 mm (nom.
7.0 mm)
100 ± 3 mm
Max. 7.2 mm (nom.
7.0 mm)
Classification per IEC 60601-1 Protection class I,
degree of protection:
CF defibrillation-proof
(Automated Impella ®
Controller and Impella
®
Catheter)
Protection class I,
degree of protection:
CF defibrillation-proof
(Automated Impella ®
Controller and
Impella ® Catheter)
Protection class I,
degree of protection:
CF defibrillation-proof
(Automated Impella ®
Controller and
Impella ® Catheter)
Protection class I,
degree of protection:
CF defibrillation-proof
(Automated Impella ®
Controller and
Impella ® Catheter)
Latex content Not made with natural
rubber latex
Not made with
natural rubber latex
Not made with
natural rubber latex
Not made with
natural rubber latex
Maximum duration of use
4 days 4 days 6 days 6 days
Weaning the patient from the Impella
®
Catheter is at the discretion of the physician. The Impella
2.5 and CP Systems have been approved for ≤ 4 days and the Impella 5.0 and LD Systems have
been approved for ≤ 6 days of use. However, weaning could be delayed beyond the normal use
for temporary support as an unintended consequence of continued instability of the patient’s
hemodynamics. Inability to wean the patient from the device within a reasonable time frame
should result in consideration of a more durable form of left ventricular support.
Latex
The Automated Impella
®
Controller and Impella ®
Catheter, including all
accessories, are not made
with natural rubber latex.
9
G
E
N
E
R
A
L SY
S
TE
M
I
N
FO
R
M
A
TI
O
N