Abiomed Automated Impella Controller Manual Del Usuario página 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
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
REF 123456
123456)
Manufacturer's serial number (eg, serial
SN 123456
number 123456)
Non Sterile! The product is not sterile
Use-by date (eg, use before 2019-11-06)
2019-11-06
Do not reuse
Sterilized using ethylene oxide
Medical Device
Do Not Flush Do NOT flush
Glucose
Use glucose in the purge fluid
Table 1.3 Symbols
Impella CP with SmartAssist
® ®
IMPELLA CATHETER PARAMETERS
Speed range
Power consumption
Voltage
Maximum Mean Flow
Purging the Impella Catheter
Recommended purge fluid
Glucose concentration
Purge pressure
Infusion rate
Maximum duration of use
Catheter dimensions
Length of invasive portion
(without catheter)
Diameter
Cable length
Classification per DIN EN 60601-1
Classification per MDD 93/42/EEC
Latex
Table 1.4 Impella Catheter Parameters
PUMP METRICS SPECIFICATIONS
Frequency
Pump Outlet (Aortic) Pressure
Pump Inlet (Left Ventricular) Pressure
Pulse Pressure
Native Cardiac Output
Cardiac Power Output
* the measured root mean square error (of multiple measurements)
Table 1.5 Pump Metrics Specifications
Metrics displayed are not intended for diagnostic use. All parameters
displayed must be verified independently using either a cleared or
approved diagnostic device, and must not be used for patient monitoring.
Impella CP ® with SmartAssist
®
0 to 46,000 rpm
24 W
Max. 20 V DC
3.7 L/min
5% glucose solution 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)
300 cm
Protection class II, degree of
protection: CF (Automated Impella
Controller and Impella Catheter)
Class III
Not made with natural rubber latex
Range Accuracy
*
0 - 200 mmHg 4.2 mmHg
0 to 200 mmHg 5.3 mmHg
1 to 100 mmHg 3.5 mmHg
0 to 5.0 L/min. 0.4 L/min.
0 to 3.0 Watts 0.2 Watts
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