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SYMBOLS
2023-11-30
123456
123456
2023-11-30
Glucose
Do Not Flush
Do Not Clean with Alcohol
16
Caution; follow instructions for use
Defibrillator-proof type CF equipment
Keep dry
Storage temperature
(e.g. 10°C to 25°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, 2023-11-30)
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)
Use-by date
(eg, use before 2023-11-30)
Do not reuse
Sterilized using ethylene oxide
Medical Device
Federal (USA) law restricts this device
to sale by or on order of a physician:
Prescription only.
Do not use if package is damaged
Single sterile barrier system with
protective packaging inside
Use glucose in the purge fluid
Do Not Flush with syringe
Do not use alcohol or alcohol-based
products for cleaning.
IMPELLA 5.5 CATHETER PARAMETERS
Speed range
Power consumption
Voltage
Flow-Maximum
Flow at 60 mmHg differential pressure
Purging the Impella 5.5 Catheter
Recommended purge fluid
Glucose concentration
Purge pressure
Purge flow
Duration of use
Dimensions of Impella 5.5 Catheter
Length of invasive portion (without catheter)
Diameter (Motor)
Diameter (Cannula)
Classification per DIN EN 60601-1
Classification per MDR (EU) 2017/745
Latex
Impella 5.5 Set Storage Temperature
0 to 33,000 rpm
Less than 16 W
Max. 20 V DC
5.5 L/min
4.4 L/min
5% glucose solution with
heparin (25 or 50 IU per mL)
or sodium hydrogen carbonate
(25 or 50 mEq/L)
5% to 20%
300 to 1100 mmHg
2 to 30 mL/hr
Up to 29 days
114 mm
18 Fr (6 mm)
21 Fr (7 mm)
Protection class I, degree of
protection:
CF (Automated Impella
Controller and Impella 5.5
Catheter)
Class III
Not made with natural rubber
latex
10°C to 25°C
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