Distributor In The Us/Contact In Canada For Product Information And Complaints; Technical Data - Aesculap FLEXHeart system Instrucciones De Manejo

Sterilization for the US market
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Aesculap advises against sterilizing the device by flash sterilization or chemical sterilization.
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Sterilization may be accomplished by a standard prevacuum cycle in a steam autoclave.
To achieve a sterility assurance level of 10 -6 , Aesculap recommends the following parameters:
Aesculap Orga Tray/Sterile container (perforated bottom)
Minimum cycle parameters*
Sterilization method Temp.
Prevacuum 270 °F/275 °F
*Aesculap has validated the above sterilization cycle and has the data on file. The validation was accomplished in an
Aesculap sterile container cleared by FDA for the sterilization and storage of these products. Other sterilization cycles
may also be suitable, however individuals or hospitals not using the recommended method are advised to validate
any alternative method using appropriate laboratory techniques. Use an FDA cleared accessory to maintain sterility
after processing, such as a wrap, pouch, etc.
Storage
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Store sterile products in germ-proof packaging, protected from dust, in a dry, dark, temperature-controlled area.
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Store sterile packed single-use products dust-protected in a dry, dark and temperature-controlled room.
Technical Service
Risk of injury and/or malfunction!
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Do not perform any servicing or maintenance work under any circumstances
while the product is being used on a patient.
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Do not modify the product.
WARNING
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For service and repairs, please contact your national B. Braun/Aesculap agency.
Modifications carried out on medical technical equipment may result in loss of guarantee/warranty rights and for-
feiture of applicable licenses.
Service addresses
Aesculap Technischer Service
Am Aesculap-Platz
78532 Tuttlingen / Germany
Phone: +49 (7461) 95 -1601
Fax: +49 (7461) 14 -939
E-Mail: ats@aesculap.de
Or in the US:
Aesculap Inc.
Attn. Aesculap Technical Services
615 Lambert Pointe Drive
Hazelwood
MO, 63042 USA
Aesculap Repair Hotline
Phone: +1 (800) 214 -3392
Fax: +1 (314) 895 -4420
Other service addresses can be obtained from the address indicated above.
Accessories/Spare parts
Art. no. Designation
FC561205 Sealing plug
FC563SU Secretion container
GA464R Compressed air hose with recycling (3 m)
GA466R Compressed air hose with recycling (5 m)
RT043R CO cartridge adapter
2
RT044SU CO cartridge
2

Technical data

Performance data, information about standards
Protection class according to IEC / DIN EN
60601-1
Applied part
Mains voltage ranges
Current consumption (maximum load)
Frequency
Compressed-air supply
Negative pressure (vacuum source)
Weight
Dimensions
(L x W x H)
Conforming to standard
EMC
Time Minimum drying time
4 min 20 min
Protection class 2
Type CF
100 V~ – 240 V~ / (+/- 10 %)
300 mA – 150 mA (at 100 V~ – 240 V~)
50 Hz-60 Hz
8 bar–12 bar
400 mmHg
FC560SU: 470 g +/-10 % (incl. accessories)
FC561: 470 g +/-10 %
FC562: 665 g +/-10 %
FC560SU: 279 mm x 32 mm x 29 mm +/-5 % (without hoses)
FC561: 132 mm x 52 mm x 50 mm +/-5 %
FC562: 128 mm x 110 mm x 60 mm +/-5 % (without power sup-
ply and cable)
IEC/DIN EN 60601-1
IEC/DIN EN 60601-1-2
Ambient conditions
Operation
Temperature 10 °C to 40 °C
Relative humidity 30 % to 75 %
Atmospheric pressure* 700 hPa to 1 060 hPa
* With regard to place of installation, max. 2 000 m above sea level
Electromagnetic tolerance
Guidelines and manufacturer declaration - Electromagnetic Emissions
The FLEXHeartSystem is intended for operation in an electromagnetic environment as described below. The sys-
tem user should make sure that the system is operated in a commensurate environment.
Emissions test Compliance
HF emissions pursuant to CISPR 11 Complies with group
1
Emissions of harmonics pursuant to Class A
IEC 61000-3-2
Emissions of voltage fluctua- Complies
tions/flicker pursuant to IEC 61000-
3-3
HF emissions pursuant to CISPR 11 Class B
Disposal
Note
The user institution is obliged to reprocess the product FC561 before its disposal, see Validated reprocessing procedure.
Adhere to national regulations when disposing of or recycling the products FC560SU, FC561
and FC562, and their components and packaging!
The recycling pass can be downloaded from the Extranet as a PDF document under the
respective article number. (The recycling pass includes disassembling instructions for the
product, as well as information for proper disposal of components harmful to the environ-
ment.)
Products carrying this symbol are subject to separate collection of electrical and electronic
devices. Within the European Union, disposal is taken care of by the manufacturer as a free-
of-charge service.
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Detailed information concerning the disposal of the product is available through your national B. Braun/Aesculap
agency, see Technical Service.
Distributor in the US/Contact in Canada for product information and
complaints
Aesculap Inc.
3773 Corporate Parkway
Center Valley, PA, 18034,
USA
TA-Nr. 014748 01/17 V6
Storage and transport
-10 °C to 50 °C
10 % to 90 %
500 hPa to 1 060 hPa
Electromagnetic Environment - Guidelines
The system uses HF energy exclusively for its
internal function. Therefore, its RF emissions are
very low and are not likely to cause any inter-
ference in nearby electronic equipment.
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The system is suitable for use in all facilities
including those in a residential area, which are
directly connected to the public power supply.