Abiomed Impella 5.0 Gebrauchsanweisung Seite 13

SYMBOLS
Caution; follow instructions for use
Defibrillator-proof type CF equipment
Keep dry
Storage temperature (eg, 10°C to 30°C)
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)
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)
123456
Manufacturer's serial number (eg, serial number
123456)
123456
Use-by date (eg, YYYY-MM-DD)
YYYY-MM-DD
Do not reuse
Sterilized using ethylene oxide
Medical Device
Use glucose in the purge fluid
Impella 5.0 ® Circulatory Support System
WHITE CONNECTOR CABLE
Length 2.5 m
Service life Single use only
IMPELLA 5.0 CATHETER PARAMETERS
®
Speed range
Power consumption
Voltage
Flow-Maximum
Purging the Impella 5.0 Catheter
®
Recommended purge fluid
Dextrose concentration
Purge pressure
Purge
Maximum duration of use
EU and Canada
Reliability
Dimensions of Impella 5.0 Catheter
Length of invasive portion (without
catheter)
Diameter
Classification per DIN EN 60601-1
Classification per directive 93/42/EEC
Latex free
0 to 33,000 rpm
Less than 1.07 W
Max. 18 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
140 ± 3 mm
Max. 7.2 mm (nom. 7.0 mm)
Protection class I, degree of
protection:
CF (Automated Impella Controller
and Impella 5.0 Catheter)
Class III
Yes
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