Abiomed Automated Impella Controller Manual De Usuario página 19

SYMBOLS
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 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)
2014-10-01
Protect from sunlight
Symbol for lot designation; the manufacturer's
lot designation must be stated after the LOT
symbol
REF 123456
Abiomed part number (eg, part number 123456)
Manufacturer's serial number (eg, serial number
SN 123456
123456)
Non Sterile! The product is not sterile
Use-by date (eg, use before June 1, 2016)
2016-06-01
Do not reuse
AIC MECHANICAL SPECIFICATIONS
Parameter Specification
Model Number 0042-0010-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.)
Automated Impella Controller with SmartAssist
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 the
NaCl
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.
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