Product Description; Operating Principle; Preparation And Setup - Aesculap FLEXHeart system Instrucciones De Manejo

FLEXHeart clamp FC561
Risk of injury due to mechanical forces!
►
Do not open the product.
WARNING
Note
The product contains sensors which may react strongly to strong magnetic influences with failure functions.
►
Remove the transport packaging and clean the new product, either manually or mechanically, prior to its initial
sterilization.
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Store any new or unused products in a dry, clean, and safe place.
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Prior to each use, inspect the product for: loose, bent, broken, cracked, worn, or fractured components.
►
Do not use the product if it is damaged or defective. Set aside the product if it is damaged.
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Replace any damaged components immediately with original spare parts.
FLEXHeart adapter FC562
Risk of death by electric shock!
►
Do not open the product.
►
Do not operate the product above 2 000 meters above sea level.
DANGER
Fire and explosion hazard!
►
Do not use oxygen as a compressed-air supply.
WARNING
The product will become hot in a case of failure!
►
If there is a failure function of FLEXHeart-System: pull the plug.
►
If the activation LED continually shows(blue): pull the plug.
CAUTION
Note
The product contains electromagnetic components which can react to strong external influences by malfunctioning.
►
Pay attention to any magnetic influences at the place of installation!
►
Inspect the new product after removing its transport packaging and prior to first use to ensure it is in good work-
ing order.
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Only pull cables by the plug.
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To protect the product against impact and knocks, preferably hang it by the hook rather than place it on the floor.

Product description

Scope of supply
Art. no. Designation
TA022130 Notes on electromagnetic compatibility (EMC)
Components required for operation
Art. no. Designation
FC560SU FLEXHeart tissue stabilizer
FC561 FLEXHeart clamp
FC562 FLEXHeart adapter

Operating principle

The FLEXHeart system is electrically operated. Patient and user are secured against electrical influences in multiple
ways.
The FLEXHeart tissue stabilizer is always safely locked in place without using a power or compressed air supply.
If during the surgical procedure the hybrid hose needs to be re-positioned, it can be briefly removed from both the
FLEXHeart clamp and the FLEXHeart adapter at any time and re-connected after correcting its position.
The same applies for the power supply and compressed air hose of the FLEXHeart adapter, if these need to be re-
positioned.
While the hybrid hose or other supply lines are removed, it is not possible to release and move the FLEXHeart tissue
stabilizer.

Preparation and setup

Non-compliance with the following instructions will preclude all responsibility and liability in this respect on the
part of Aesculap.
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When setting up and operating the product, adhere to
– national regulations for installation and operation,
– national regulations on fire and explosion protection.
Set-up environment/set-up location
Fire and explosion hazard!
►
Use the product outside of explosion hazard zones (e.g. areas with highly pure
oxygen or anesthetic gases).
DANGER
The device is authorized for operation in the operating room.
Note
The FLEXHeart adapter FC562 is intended for operation in the non-sterile zone.
►
Make sure that the operating elements, plug and outlet of the building installation are accessible to the user.
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Make sure that the plug is accessible to the user.
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Make certain that the device is not exposed to continuous vibrations at the place of installation.
Connecting the power supply
The mains voltage must be 100 – 240 V AC depending on the country.
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Plug the country-specific adapter supplied with the product into the power supply.
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Ensure that the adapter is suitable for the electrical installation of the building.
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Connect power supply by inserting into a wall socket.
The green LED on the mains plug lights up.
Mounting/changing adapters
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Press the button under the electrical contacts on the wall side of the power supply and keep it pressed down, see
Fig. G.
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Slide the adapter up and out.
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Insert the other adapter from above.
The adapter clicks audibly in place.
Connecting the compressed-air supply
The compressed air supply must be set to a value in the range of 8 – 12 bar (116 – 174 psi).
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Read and follow instructions for use TA013148 (for RT043/RT044SU only).
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Connect the FLEXHeart adapter with compressed air hose and Aesculap connector to the compressed air supply
of the operating room or use Aesculap CO
2
Note
If using the Aesculap CO cartridge adapter and CO
2
ficient for 30 activations. For complex operations with several bypasses, the cartridge may need to be replaced.
Note
Heavy or sluggish movement of the FLEXHeart tissue stabilizer indicates that the CO
Working with the FLEXHeart system
System set-up
Risk of infection and contamination!
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Prior to use, carry out sterile processing of the FLEXHeart clamp FC561, which
is supplied in unsterile condition, in accordance with the instructions for use.
WARNING
Connecting the accessories
Risk of injury due to unapproved configuration using additional components!
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For all applied components, ensure that their classification matches that of the
application component (e.g. Type BF or Type CF) of the respective device.
DANGER
Combinations of accessories that are not mentioned in the present instructions for use may only be employed if they
are specifically intended for the respective application, and if they do not compromise the performance and safety
characteristics of the products.
All configurations must comply with basic standard IEC/DIN EN 60601-1. Any individual connecting devices with
one another is responsible for such configuration and must ensure compliance with basic standard IEC/DIN
EN 60601-1 or applicable national standards.
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Please address your B. Braun/Aesculap partner or Aesculap Technical Service with any inquiries in this respect;
for a contact address, see Technical Service.
Mounting the FLEXHeart clamp on the sternal retractor
The locking clamping device is compatible with most sternal retractors for adults. The device covers a cross-sectional
area of 3.5 mm to 8.8 mm in height and 10.8 mm to 26.3 mm in width.
Risk of injury and/or malfunction due to incorrect attachment of the FLEXHeart
clamp!
►
Check the clamp is securely attached to the sternal retractor by moving the
FLEXHeart clamp.
WARNING
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Check the compatibility of the sternal retractor before use.
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Grasp the clamping mechanism of the locking clamping device from the side, move it back, place it on the sternal
retractor and release.
The clamping mechanism is now mounted on the sternal retractor.
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Turn the clamping lever 90° counterclockwise, see Fig. D.
The clamping lever is parallel to the housing of the FLEXHeart clamp.
FLEXHeart clamp is attached to the sternal retractor.
Connecting the FLEXHeart clamp to the FLEXHeart adapter
Malfunction due to damaged hybrid hose!
►
Do not damage the hybrid hose with instruments, sharp edges or by crushing.
CAUTION
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Remove the sealing plug from the socket of the FLEXHeart clamp.
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Connect the sterile hybrid hose of the FLEXHeart tissue stabilizer FC560SU to the FLEXHeart clamp, see Fig. D.
►
Connect the sterile hybrid hose to the FLEXHeart adapter.
Connecting the FLEXHeart tissue stabilizer to the FLEXHeart clamp
Risk of crush injury when connecting the FLEXHeart tissue stabilizer to the
FLEXHeart clamp!
►
Hold the FLEXHeart tissue stabilizer by the handles from the side when con-
necting it, see Fig. C.
WARNING
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Place the FLEXHeart tissue stabilizer on the guide of the FLEXHeart clamp and move it down as far as it will go,
see Fig. F.
The articular arm locks in place automatically as soon as it reaches the end position.
Connecting the FLEXHeart tissue stabilizer to the vacuum source
Note
The shut-off valve is used to supply/shut-off the negative pressure at the operating site during the surgery.
►
Set the negative pressure on the external vacuum source to a maximum of 400 mmHg.
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Connect the suction hose of the FLEXHeart tissue stabilizer to the negative pressure hose with shut-off valve.
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Connect the negative pressure hose to the shut-off valve and this to the vacuum source.
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If necessary, connect a secretion container e.g. FC563SU between the negative pressure hose and vacuum source.
– Apply the secretion container in a vertical position.
– Do not fill beyond the maximum filling volume.
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Do not kink, compress or pull on the negative pressure hose.
cartridge adapter and CO cartridge RT043 and RT044SU.
2
cartridge RT043 and RT044SU, the content of the cartridge is suf-
2
cartridge is spent.
2