General Information; Validated Reprocessing Procedure - Aesculap FLEXHeart system Instrucciones De Manejo

Function checks
►
Check that suction is present on the stabilizer foot.
Safe operation
Risk of injury and/or malfunction!
►
Always carry out a function check prior to using the product.
WARNING
Risk of injury when using the product beyond the field of view!
►
Apply the product only under visual control.
WARNING
Positioning the FLEXHeart tissue stabilizer
Risk of unlocking the FLEXHeart tissue stabilizer due to unintentional activation
of the activation elements!
►
Always keep the upper side of the FLEXHeart clamp clear.
WARNING
►
When undoing and moving the FLEXHeart tissue stabilizer: Hold the distal end in your hand.
►
Press one of the two activation elements on the distal end of the FLEXHeart tissue stabilizer or on the FLEXHeart
clamp and keep pressed down.
The FLEXHeart tissue stabilizer can be moved.
If the activation element is released, the FLEXHeart tissue stabilizer is locked in the current position.
Bending the paddles on the stabilizer foot
The stabilizer foot has deformable paddles which can be adapted to the heart, see Fig. C.
Damage to the stabilizer foot and failure of the suction due to excessive deform-
ing!
►
Bend the paddles on the stabilizer foot a maximum of 10° each side.
►
Deform the deformable paddles with care.
WARNING
►
Never make more than 10 deforming actions.
Risk of injury/impairment of the operating site!
►
Only establish the bypass when the stabilizer foot is correctly positioned on the
heart surface and the FLEXHeart tissue stabilizer is locked in place.
WARNING
Moving the stabilizer foot intraoperatively
Risk of injury/impairment of the operating site!
►
Close the shut-off valve so that there is no negative pressure at the working
end.
►
Carefully remove the stabilizer foot from the heart surface.
WARNING
►
Turn the shut-off valve of the negative pressure hose 90°, see Fig. H.
►
The suction is interrupted.
►
Remove the stabilizer foot from the heart surface and move it to a new position.
►
Open the shut-off valve.
Moving the hybrid hose intraoperatively
►
Remove the hybrid hose from the FLEXHeart clamp and/or from the FLEXHeart adapter by pressing on the latch
noses of the connector from the side.
►
Move the hybrid hose.
►
Reconnect the hybrid hose to the FLEXHeart clamp and/or FLEXHeart adapter.
Disassembly
►
Turn the shut-off valve of the negative pressure hose 90°.
►
Remove the stabilizer foot from the heart surface.
►
Grasp the proximal end of the FLEXHeart tissue stabilizer from the side.
►
Press the activation element on the FLEXHeart clamp and keep it pressed down.
►
Move the FLEXHeart tissue stabilizer upwards to remove it from the guide of the FLEXHeart clamp.
►
Remove the negative pressure hose with shut-off valve from the vacuum source.
►
Remove the hybrid hose from the FLEXHeart clamp and FLEXHeart adapter by pressing on the latch noses of the
connector from the side.
►
Turn the clamping lever of the FLEXHeart clamp 90° clockwise.
The clamping lever is at a right angle to the housing of the FLEXHeart clamp.
►
Grasp the clamping mechanism from the side, move it back and remove the FLEXHeart clamp from the sternal
retractor.
►
Dispose of the FLEXHeart tissue stabilizer FC560SU including hybrid hose and negative pressure hose with shut-
off valve.
Putting out of operation
Note
The safe and all-pole disconnection of the product from the main power supply is only guaranteed when the power
cord is unplugged.
►
Unplug the mains plug from the wall socket.
The operation of the device is safely terminated.

Validated reprocessing procedure

General safety instructions
Note
Adhere to national statutory regulations, national and international standards and directives, and local, clinical
hygiene instructions for sterile processing.
Note
For patients with Creutzfeldt-Jakob disease (CJD), suspected CJD or possible variants of CJD, observe the relevant
national regulations concerning the reprocessing of products.
Note
Mechanical reprocessing should be favored over manual cleaning as it gives better and more reliable results.
Note
Successful processing of this medical device can only be ensured if the processing method is first validated. The oper-
ator/sterile processing technician is responsible for this.
The recommended chemistry was used for validation.
Note
If there is no final sterilization, then a virucidal disinfectant must be used.
Note
For up-to-date information about reprocessing and material compatibility, see also the Aesculap Extranet at
https://extranet.bbraun.com
The validated steam sterilization procedure was carried out in the Aesculap sterile container system.

General information

Dried or affixed surgical residues can make cleaning more difficult or ineffective and lead to corrosion. Therefore the
time interval between application and processing should not exceed 6 h; also, neither fixating pre-cleaning temper-
atures >45 °C nor fixating disinfecting agents (active ingredient: aldehydes/alcohols) should be used.
Excessive measures of neutralizing agents or basic cleaners may result in a chemical attack and/or to fading and the
laser marking becoming unreadable visually or by machine for stainless steel.
Residues containing chlorine or chlorides e.g. in surgical residues, medicines, saline solutions and in the service water
used for cleaning, disinfection and sterilization will cause corrosion damage (pitting, stress corrosion) and result in
the destruction of stainless steel products. These must be removed by rinsing thoroughly with demineralized water
and then drying.
Additional drying, if necessary.
Only process chemicals that have been tested and approved (e.g. VAH or FDA approval or CE mark) and which are
compatible with the product's materials according to the chemical manufacturers' recommendations may be used
for processing the product. All the chemical manufacturer's application specifications must be strictly observed. Fail-
ure to do so can result in the following problems:
■
Optical changes of materials, e.g. fading or discoloration of titanium or aluminum. For aluminum, the applica-
tion/process solution only needs to be of pH >8 to cause visible surface changes.
■
Material damage such as corrosion, cracks, fracturing, premature aging or swelling.
►
Do not use metal cleaning brushes or other abrasives that would damage the product surfaces and could cause
corrosion.
►
Further detailed advice on hygienically safe and material-/value-preserving reprocessing can be found at www.a-
k-i.org, link to Publications, Red Brochure – Proper maintenance of instruments.
Preparations at the place of use
►
Remove any visible surgical residues to the extent possible with a damp, lint-free cloth.
►
Transport the dry product in a sealed waste container for cleaning and disinfection within 6 hours.
Preparation before cleaning
►
Carry out non-fixating/NaCl-free pre-cleaning immediately after use.
►
Insert the sealing plug into the socket of the FLEXHeart clamp, see Fig. D.
Note
If the sealing plug shows external damage, its sealing action and therefore the correct reprocessing of the FLEXHeart
clamp is no longer assured.
►
If necessary, use a new sealing plug FC651205.
Cleaning/disinfection
Product-specific safety instructions for the reprocessing procedure
FLEXHeart clamp FC561
Danger to the patient!
►
Reprocess the product only with manual pre-cleaning followed by mechanical
cleaning.
DANGER
Damage to the product due to inappropriate cleaning/disinfecting agents and/or
excessive temperatures!
►
Use cleaning and disinfecting agents according to the manufacturer's instruc-
tions which
CAUTION
– which are approved for (e.g., plastics/high-grade steel/aluminum).
– do not attack softeners (e.g. in silicone).
►
Observe specifications regarding concentration, temperature and exposure
time.
►
Do not exceed the maximum temperature of 60 °C during chemical cleaning
and/or disinfection.
►
Do not exceed the maximum temperature of 90 °C during thermal disinfection
with FD water.
►
Dry the product for at least 10 minutes at a maximum of 120 °C.
Note
The indicated drying temperature is a guide temperature only. It must be checked taking into account the specific con-
ditions (e.g. load) and if applicable adjusted.
Note
The predicted life of the FLEXHeart clamp FC561 is at least 300 uses and preparations if used as intended.
FLEXHeart adapter FC562
Risk of electric shock and fire hazard!
►
Unplug the device before cleaning.
►
Do not use flammable or explosive cleaning or disinfecting solutions.
►
DANGER Ensure that no fluids will penetrate the product.
Damage to, or destruction of the product caused by mechanical cleaning/disinfec-
tion!
►
Only clean and disinfect the product manually.
►
Do not sterilize the product under any circumstances.
CAUTION
Damage to the product due to inappropriate cleaning/disinfecting agents!
►
Only use cleaning/disinfecting agents approved for surface cleaning. Follow
the manufacturer's instructions for the respective cleaning/disinfecting agent.
CAUTION