Inhoudsopgave
Advertenties
Beschikbare talen
Beschikbare talen
SYMBOLS
Table 1.3 Symbols
Caution; follow instructions for use
Defibrillator-proof type CF equipment
Keep dry
+30°C
Storage temperature (eg, 10°C to 30°C)
+10°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, 2019-11-30)
2019-11-30
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)
123456
Manufacturer's serial number (eg, serial
number 123456)
123456
2019-11-30
Use-by date (eg, use before 2019-11-30)
Do not reuse
Sterilized using ethylene oxide
Medical Device
Do not use if package is damaged
Single sterile barrier system with protective
packaging inside
Do Not Flush
Do NOT flush
Glucose
Use glucose in the purge fluid
Impella CP
with SmartAssist
®
®
IMPELLA CATHETER PARAMETERS
Table 1.4 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 Protection class I, degree of
Classification perRegulation (EU)
2017/745
Latex
PUMP METRICS SPECIFICATIONS
Table 1.5 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)
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: 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
11
Advertenties
Inhoudsopgave
