Safe Operation - Aesculap Caiman 5 Instrucciones De Manejo/Descripción Técnica

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Aesculap
Caiman 5 Articulating, Sealing & Cutting Instruments
Legend
Instrument
1 HF activation button
2 Rotation wheel
3 Jaw articulation
4 Moveable jaw part with marking
5 Articulation activation lever
6 Blade activation lever
7 Jaw part activation lever
8 HF cable with connector
Generator
9 SEE LEKTRAFUSE HF GENERATOR IFU
10 Foot switch connection socket
11 Regrasp signal lamp
12 Display
13 Error signal lamp
14 Instrument connection socket
15 "Power on" indicator light
16 Foot control switch
Symbols on product and packages
Sterilization with irradiation
Not for reuse in intended applications as defined by the manufacturer
Use by
Caution, general warning symbol
Caution, see documentation supplied with the product
Follow the instructions for use
Date of manufacture
Scope
Aesculap Caiman 5 Articulating, Sealing & Cutting Instruments are sterile, disposable instruments. Caiman 5 instru-
ments with the Aesculap Lektrafuse HF generator form an HF system for applying HF energy. Caiman 5 instruments
can only be used in conjunction with the Lektrafuse HF generator.
The user can seal and cut tissue to a length of up to 26.5 mm with Caiman 5 instruments. The energy input into the
tissue is controlled by the Lektrafuse generator software.
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For item-specific instructions for use and information regarding material compatibility, see Aesculap Extranet at
www.extranet.bbraun.com
Intended use
Indications
Caiman 5 instruments are used for grasping, dissecting, sealing and cutting tissue during open and laparoscopic sur-
gical procedures.
Caiman 5 instruments can be used on vessels with a diameter of up to and including 7 mm.
Contraindications
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There is no evidence that the Caiman 5 instruments are suitable for tube sterilization, coagulation of the fallo-
pian tubes, etc. Therefore the product is strictly not to be used in sterilization procedures.
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Use on vessels with a diameter of greater than 7 mm. Particular caution must be exercised in case of pathological
changes of vessels with a diameter of less than 7 mm, e.g. atherosclerosis.
As the safe and effective use of electrosurgical instruments is in principle greatly dependent on influencing factors
that only the user can control, the above information can only be used as general guidance only. The clinically suc-
cessful use of such products is dependent on the knowledge and experience of the surgeon, who is responsible for
deciding which structures can be reasonably treated, taking into account the safety and warning instructions given
in these instructions for use.
Safe handling and preparation
Risk to the patient and/or user when using the Caiman 5 instruments with HF
sources other than the Lektrafuse HF generator!
Non-observance can result in injury or death and restriction in the function of the
Caiman 5 instruments.
DANGER
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Use Caiman 5 instruments only with the Lektrafuse HF generator.
Risk of death or injury to the patient through non-observance of the following
directions!
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Use Caiman 5 instruments with caution on patients with cardiac pacemakers
or defibrillators.
DANGER
Risk of injury due to evaporation of tissue fluid!
During the sealing process, tissue fluid can be converted into steam by the HF
energy. This can result in collateral damage to the directly neighboring tissue.
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Observe the sealing process carefully.
WARNING
Risk of injury caused by incorrect operation of the product!
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Do not activate the HF current before the Caiman 5 instrument has been com-
pletely closed and the lock is activated.
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Do not open Caiman 5 instruments during the HF process as this will automat-
WARNING
ically interrupt the sealing process.
Risk of injury from ignition or explosion of flammable gases!
Sparks may occur when using the Lektrafuse HF generator as directed.
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Follow the safety notes in the instructions for use of the Lektrafuse HF gen-
erator.
WARNING
Risk of insufficient sealing due to contaminated electrode surfaces!
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Keep the product's contact surfaces clean during surgery. Remove encrusted
tissue residues or body fluids with a moistened swab.
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When cleaning the electrodes:
WARNING
Do not activate the HF current.
Do not immerse the device jaws in liquid, including saline solution.
Do not clean the device jaws with abrasives.
Risk of injury to patient or damage to the instrument when removing the
Caiman 5 instrument with distally articulated jaw part!
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Check the compatibility of the trocar and the Caiman 5 instrument.
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Before inserting or removing the Caiman 5 instrument, place the articulation
WARNING
mechanism in the neutral position.
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Insert the Caiman 5 instrument into the trocar and remove it only when
locked, and carefully.
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Ensure that the product and its accessories are operated and used only by persons with the requisite knowledge
and experience.
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Read, follow, and keep the instructions for use.
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Only use product after consulting the instructions for use of the Lektrafuse HF generator GN200.
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Use the product only in accordance with its intended use, see Intended use.
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Prior to each use, inspect the product for loose, bent, broken, cracked or fractured components.
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Do not use the product if it is damaged or defective. Set aside the product if it is damaged.
The product is gamma-sterilized and supplied in sterile packaging.
The product must not be reused.
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Do not use products from open or damaged sterile packaging.
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Do not use the product after its use-by date.
The accessory voltage rating of the product is 240 Vp.
To avoid HF burns:
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Always keep the working end of the product in the user's field of vision whenever the HF power is activated.
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Prior to activating the Lektrafuse HF generator, check that the working end of the product is not touching any
electrically conductive accessories.
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Never place the product on or next to the patient.

Safe operation

Risk of injury when using the product beyond the field of view!
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Apply the product only under visual control.
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Before activating product, ensure that no electrically conductive objects are in
contact.
WARNING
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Do not place the product on or next to the patient.
Risk of damage to the tissue or the instrument due to incorrect use of the instru-
ment with the lock engaged!
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Avoid the following actions when the lock is activated:
Rotation of the shaft
WARNING
Articulation of the jaw parts
Risk of insufficient sealing or transection of the tissue!
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Do not bundle or fold the tissue which is to be sealed and cut, or clamp more
than one layer between the jaw parts.
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Grip the tissue that is to be sealed centrally between the electrodes.
CAUTION
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Do not start the process if the instrument jaws are in conductive liquids (e.g.
blood or saline solution).
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Do not start the process if there are conductive objects (e.g. clamps, vessel
clamps, clips, etc.) between the instrument jaws.
The software of the Lektrafuse HF generator recognizes the Caiman 5 instruments and applies the corresponding
device settings. The duration of the sealing process is controlled by the generator software.
The sealing process is started by tapping on an HF button once. The sealing process is interrupted by again tapping
an HF activation button.
Note
In case of unsuccessful or incomplete sealing, as well as insufficient functionality of the instruments, a visual and
acoustic alarm will be generated by the generator.
Note
In the event of visibly insufficient sealing of the tissue, the sealing quality can be improved by again activating the HF
process.
Tissue manipulation, sealing of vessels and tissue bundles and tissue separation
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Remove the Caiman 5 instrument from the sterile packaging.
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Insert the plug 8 of the Caiman 5 product into the connecting socket 14 of the Lektrafuse HF generator.
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In order to bring the jaw parts into the desired position, turn the rotation wheel 2. Whilst doing this, ensure that
the black line of the rotation wheel 2 indicates the central position.
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Bring the tip of the instrument into the desired position for surgery by rotating the shaft and applying an artic-
ulation movement to the articulation activation lever 5.
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Grip the tissue that is to be sealed and/or cut between the jaw parts.
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Lock the moveable jaw part 4 using the activation lever 7.
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In order to seal the clamped tissue, actuate the HF activation button 1 on the instrument or foot switch 16.
Note
For additional options see the instructions for use of the Lektrafuse HF generator GN200.