Abiomed Impella 2.5 Manual Del Usuario página 14

SYMBOLS
2019-11-06
REF 123456
SN 123456
Non Sterile!
2019-11-06
Do Not Flush
Glucose
NaCl
12
Caution; follow instructions for use
Defibrillator-proof type CF equipment
Keep dry
Max. 20 V DC
Declares conformity with Directive
93/42/EEC for medical devices or with
Regulation (EU) 2017/745 on medical
devices, and with Directive 2011/65/EU
on the restriction of the use of certain
hazardous substances in electrical and
electronic equipment
Date of manufacture (eg, 2019-11-06)
Protect from sunlight
Symbol for lot designation; the
manufacturer's lot designation must be
stated after the LOT symbol
Abiomed part number
(eg, part number 123456)
Manufacturer's serial number
(eg, serial number 123456)
The product is not sterile
Use-by date
(eg, use before 2019-11-06)
Do not reuse
Sterilized using ethylene oxide
Medical Device
Do NOT flush
Use glucose in the purge fluid
Use saline in the pressure bag;
squeeze at the green arrows to flush
WHITE CONNECTOR CABLE
Length
Service life
IMPELLA CATHETER PARAMETERS
®
Impella 2.5
Speed range 0 to 51,000 rpm
Power consumption
19.8 W
Voltage Max. 20 V DC
Flow Max flow: 2.5 L/min
Purging the Impella
Catheter
5% glucose solution
Recommended purge in water with heparin
fluid concentration of 50 IU
per mL
Glucose concentration 5% to 20%
Purge pressure 300 to 1100 mmHg
Infusion rate 2 to 30 mL/h
Maximum duration
of use
Up to 5 days
EU and Canada
Catheter dimensions
130 ± 3 mm
Length of
invasive portion
(without catheter)
Max. 4.2 mm
Diameter (nom. 4.0 mm)
Classification per DIN Protection class I,
EN 60601-1 degree of protection:
CF (Automated Impella
Controller and Impella
Catheter)
Classification per
Class III
MDD/93/42/EEC
Latex free Yes
2.5 m
Single-use only
Impella CP
® ®
0 to 46,000 rpm
24 W
Max. 20 V DC
Max Mean flow: 3.3 L/min
5% glucose solution
in water with heparin
concentration of 50 IU
per mL
5% to 20%
300 to 1100 mmHg
2 to 30 mL/h
Up to 5 days
150 ± 3 mm
Max. 4.9 mm
(nom. 4.7 mm)
Protection class I,
degree of protection:
CF (Automated
Impella Controller and
ImpellaCatheter)
Class III
Yes
User Manual