Abiomed Impella Manuel D'utilisation page 16

SYMBOLS
2014-10-01
REF 123456
SN 123456
Non Sterile!
2016-06-01
AIC MECHANICAL SPECIFICATIONS
Parameter Specification
Model Number
0042-0000-EU / 0042-0000-CA
Temperature
Operating:
Storage:
Relative Operating:
Humidity Storage:
Atmospheric Operating:
Pressure
Storage:
Dimensions
Height:
Width:
Depth:
Dimensions – Height:
Packaged Width:
Depth:
Weight Maximum:
Weight Packaged Maximum:
Maintenance and 12 months (Work must be performed by technicians
repair interval authorized by Abiomed and have completed
Abiomed's Service Training Certification Program.)
16
Caution: Read, understand, and 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, October 1, 2014)
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 June 1, 2016)
Do not reuse
10 °C to 40 °C (50 °F to 104 °F)
–15 °C to 50 °C (5 °F to 122 °F)
95%
95%
8000 ft (750 hPa) to –1000 ft
(1050 hPa)
18,000 ft (500 hPa) to –1000 ft
(1050 hPa)
351 mm (13.8 in)
443 mm (17.4 in)
236 mm (9.3 in)
508 mm (20.0 in)
559 mm (22.0 in)
406 mm (15.0 in)
12.2 kg (26.8 lbs)
14.3 kg (31.5 lbs)
Sterilized using ethylene oxide
Medical Device
Electric scrap; must be disposed of
separately.
Must not be disposed of as domestic waste.
Protective Earth
ON / OFF
Alternating current (AC) only
Equipotentiality
Fuse
Non-ionizing electromagnetic radiation
USB port
CAT 5 Port (Ethernet)
MR Unsafe
Do NOT flush
Do Not Flush
Glucose
Use glucose in the purge fluid
Use saline in the pressure bag; squeeze at
NaCl
the green arrows to flush
AIC ELECTRICAL SPECIFICATIONS
AC operation 100-240 V AC, 2A, 50-60 Hz
Internal battery operation 14.4 V DC (nominal); lithium ion
Characteristic values
Max. power consumption 200 VA
under load 2 Amp. 250 V. 5 mm x 20 mm, slow-blow
9.7 fuses fuses
Running time without AC At least 60 minutes
power, with fully charged (charging duration of at least 5 hours)
batteries
Electrical system Installation in accordance with pertinent
regulations is required for use in medical
facilities (eg, VDE 0100, VDE 0107, or IEC
stipulations). Observe country-specific
regulations and national deviations.
NOTE Circuit diagrams are available upon request.
User Manual