Safe Handling - Aesculap FLEXHeart system Instrucciones De Manejo

®
Aesculap
FLEXHeart system
Key
Fig. A: FLEXHeart complete system
1 Flexible articular arm
2 Negative pressure hose with shut-off valve
3 Connection to vacuum source
4 Clamp
5 Hybrid hose
6 Adapter
7 Compressed-air connector
8 Mains power plug
Fig. B: FLEXHeart tissue stabilizer FC560SU
1 Flexible articular arm
2 Negative pressure hose with shut-off valve
3 Hybrid hose
Fig. C: Flexible articular arm
1 Stabilizer foot
2 Operating element
3 Connection point to FC561
4 Suction hose
5 Handle
6 Paddle (= Application part)
Fig. D: FLEXHeart clamp FC561
1 Connection point to flexible articular arm
2 Activation element
3 Connection point to hybrid hose
4 Sealing plug
5 Clamping lever
6 Locking clamping device
Symbols on product and packaging
Caution
Observe important safety
information such as warnings
and precautions in the
instructions for use.
Follow the instructions for use
Type CF
Alternating current
Sterilization using ethylene
oxide
Not for reuse as per the man-
ufacturer-defined intended
use
Use by
Date of manufacture
Labeling of electrical and
electronic devices according
to directive 2012/19/EU
(WEEE), see Disposal
Fig. E: FLEXHeart adapter FC562
1 Hook
2 Compressed-air connector
3 Mains plug
4 Country-specific mains adapter
5 Vent
6 Connection point to hybrid hose
Fig. F: Adaption flexible articulated arm FC561
Fig. G: Change of country-specific mains adapter
1 Operating LED (green)
2 Button
3 Plug system
Fig. H: Shut-off valve from negative pressure hose
to FC560SU
1 Negative pressure hose to vacuum source
2 2-way valve open (=suction)
3 2-way valve closed (=suction interrupted)
4 Connection point to suction hose of flexible articu-
lar arm
Manufacturer's serial number
SN
LOT Manufacturer's batch desig-
nation
Manufacturer's article num-
REF
ber
Temperature limits during
transport and storage
Air humidity limits during
transport and storage
Atmospheric pressure limits
during transport and storage
Keep device away from fluids
CE-approved in accordance
with Directive 93/42/EEC
Protection class 2
Warnings
Warnings in this document that highlight risks to the patient, user and/or product are displayed as follows:
Danger
Risk of death or serious injury.
DANGER
Warning
Risk of possible death or serious injury.
WARNING
Caution
Risk of minor injury or product damage.
CAUTION
Applicable to
►
For item-specific instructions for use and information on material compatibility, see also the Aesculap Extranet
at https://extranet.bbraun.com
Intended use
The FLEXHeart system is used for coronary surgery without a heart-lung machine (OPCAB - off pump coronary artery
bypass) to stabilize the surface of the heart as far as possible to establish a bypass.
The FLEXHeart tissue stabilizer FC560SU, FLEXHeart clamp FC561 and FLEXHeart adapter FC562 are the components
required and used in combination for the system's intended use.
The FLEXHeart tissue stabilizer has a stabilizer foot, which is connected to a vacuum source and placed over the cor-
onary vessel. The flexible articular arm can be released and locked in placed via an electric activation element.
The FLEXHeart tissue stabilizer is connected to the FLEXHeart clamp and clamped onto a sternal retractor together
with the clamp.
The FLEXHeart adapter is connected to the FLEXHeart clamp via a hybrid hose and kept in the non-sterile zone.
The FLEXHeart adapter is connected to a power and compressed air supply.
The FLEXHeart system is a medical electrical device (ME device). The FLEXHeart system meets the standards
IEC 60601-1 and DIN EN 60601-1.
Indications
The FLEXHeart system is used on the beating heart in heart surgery to stabilize a certain area of the heart surface
as far as possible for establishing a bypass.
Note
The manufacturer is not responsible for any use of the product against the specified indications and/or the described
applications.
Contraindications
The product is intended for the above-mentioned purpose of use only.
►
Do not position the stabilizer foot on a coronary artery, fresh infarction tissue or aneurysmal heart tissue.
Side effects
None known.

Safe handling

CAUTION
Federal law restricts this device to sale by, or on oder of a physician!
■
The medical specialists shall decide on the precise applicability based on the assured properties and technical
data in accordance with the intended use.
■
General risk factors associated with surgical procedures are not described in this documentation.
■
It is the operating surgeon's responsibility to ensure that the surgical procedure is performed correctly.
■
The operating surgeon must have a thorough understanding of both the hands-on and conceptual aspects of the
established operating techniques.
►
Ensure that the system is operated and used only by persons with the requisite training, knowledge, or experi-
ence.
►
Prior to use, check that the system is in full working order and in good condition.
►
Keep the instructions for use accessible for the user.
►
Observe "Notes on Electromagnetic Compatibility (EMC)", see TA022130.
►
Always adhere to applicable standards.
►
To prevent damage caused by improper setup or operation, and in order not to compromise warranty and man-
ufacturer liability:
– Use the system only according to these instructions for use.
– Follow the safety and maintenance instructions.
– Only combine Aesculap products with each other.
►
Do not immerse in liquids or excessively wet the components during use in order to prevent system failure.
FLEXHeart tissue stabilizer FC560SU
Risk of infection for patients and/or users and impairment of product functional-
ity due to reuse. Risk of injury, illness or death due to contamination and/or
impaired functionality of the product!
►
Do not reprocess the product.
WARNING
The product is EO sterilized and sterile packed.
The product must not be re-used or re-processed.
►
Do not use products from open or damaged sterile packaging.
►
Prior to each use, inspect the product for loose, bent, broken, cracked or fractured components.
►
Do not use the product if it is damaged or defective. Set aside the product if it is damaged.
►
Do not re-sterilize the product.
►
Do not use the product after its use-by date.