Aesculap
®
Bipolar, detachable tubular shaft instruments
Legend
1
Moveable ring
2
Fixed ring
3
Rotating sleeve
4
Working insert
5
Insulating outer tube
6
Inner tube
7
Pin protection
8
HF connection
9
Star wheel
10
Flexible switches
11
Groove
A
Handle
B
Sheath
Symbols on product and packages
Intended use
Bipolar, detachable tubular shaft instruments are used for the cutting, dissection, grasping, and coagulation of tissue
in minimally invasive surgery.
Safe handling and preparation
CAUTION
Federal law restricts this device to sale by, or on order of a physician!
►
Ensure that the product and its accessories are operated and used only by persons with the requisite training,
knowledge, or experience.
►
Read, follow, and keep the instructions for use.
►
Use the product only in accordance with its intended use, see Intended use.
►
Remove the transport packaging and clean the new product, either manually or mechanically, prior to its initial
sterilization.
►
Store any new or unused products in a dry, clean, and safe place.
►
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.
►
Replace any damaged components immediately with original spare parts.
►
To avoid damage to the working end: Carefully insert the product through the working channel (e.g. trocar).
The manufacturer has tested the product and verified that its insulation can withstand a certain number of repro-
cessing cycles. In clinical practice, the service life will depend on the individual intraoperative usage and the hospi-
tal's specific reprocessing conditions.
►
Prior to each use, inspect products for: damage or surface changes to the insulation.
►
Immediately sort out damaged or inoperative products and have them sent to Aesculap Technical Service, see
Technical Service.
►
Adjust the HF power output (and argon flow rate) to the intervention to be carried out. Take into account clinical
experience or reference values.
►
Select the lowest possible HF power output.
►
Keep the product’s contact surfaces clean during surgery. Remove encrusted tissue residues or body fluids with
a moistened swab.
The product is furnished with the following connection on the plug side: Aesculap flat connector.
Refer to our brochures to find a compatible cable.
The accessory voltage rating of the product is 1 000 Vp.
The accessory voltage rating must exceed or match the peak output voltage with which the product is operated in
combination with a suitable HF device at an appropriate operating mode/setting (see IEC/DIN EN 60601-2-2).
To avoid HF burns:
►
Always keep the working end of the product in the user’s field of vision whenever the HF power is activated.
►
Prior to activating the HF device, check that the working end of the product is not touching any electrically con-
ductive accessories.
►
Prior to each use, visually inspect the product for: damage or surface changes to the insulation.
►
Never place the product on or next to the patient.
►
When using accessories for endoscopy or laparoscopy, deactivate the automatic switch-on mode of the HF
device.
►
Follow the instructions for use of the HF device.
Safe operation
From the health-and-safety perspective, bipolar is a better alternative than monopolar coagulation, because the cur-
rent does not flow through the whole body, but only through a narrowly defined tissue region from one jaw piece/
scissor blade to the other jaw piece/scissor blade.
Note
If both jaw pieces come into direct contact, coagulation cannot occur as the power source is short-circuited.
The coagulation will be particularly safe and effective if the tissue is grasped and appropriately compressed before
the HF current is activated.
►
Make certain the grasping surfaces are clean and metallic bright.
Mode of operation of the bipolar scissors
The most effective coagulation will be achieved by first compressing the tissue between the two scissor blades and
then cutting slowly through the tissue while the HF current is activated.
The slower the cut, the larger the coagulation zone at the edge of the cut.
Note
To ensure effective coagulation, make certain, e.g., by setting the scissor blades at various angles to the tissue, that
the tissue cut by the metal-ceramic scissor blade is in contact with the metal part, see Fig.
2
.
Grasping variants
The bipolar handle
A
can be operated either in the traditional ring grip hold or in the more ergonomic hand-embrace
hold, see Fig.
7
.
Disassembling
Removing the pin protector
►
Compress pin protector
7
and slide it off carefully towards the sheath, see Fig.
3
.
Releasing the handle A/sheath B connection
►
Pull back rotating sleeve
3
in the direction of the arrow (towards the handle
A
) as far as it will go, see Fig.
4
.
►
Hold the sleeve to the stop while simultaneously pulling out the sheath
B
with moveable ring
1
left loose, see
Fig.
4
.
Disassembling the sheath B
►
Slide off insulating outer tube
5
.
►
Detach inner tube
6
from working insert
4
, see Fig.
1
.
Assembling
Assembling the sheath B
►
Slide inner tube
6
onto working insert
4
until leaf springs
10
snap into position, see Fig.
5
.
►
Slide insulating outer tube
5
over inner tube
6
with working insert
4
as far as it will go, see Fig.
5
.
Establishing the handle A/sheath B connection
►
Pull back rotating sleeve
3
in the direction of the handle
A
as far as it will go and hold it there, see Fig.
6
.
►
Swivel moveable ring
1
towards distal. Grasp the sheath
B
at working insert
4
and slightly rotate and push it into
handle
A
until the rotating sleeve
3
snaps towards distal, see Fig.
6
.
Attaching the pin protector
►
Compress pin protector
7
and guide it carefully over the jaw pieces. Engage the pin protector in groove
11
of
working insert
4
, see Fig.
8
.
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 the latest information on reprocessing and material compatibility see also the Aesculap extranet at
www.extranet.bbraun.com
The validated steam sterilization procedure was carried out in the Aesculap sterile container system.
Caution, general warning symbol
Caution, see documentation supplied with the product
Date of manufacture
WARNING
Risk of injury from ignition or explosion of flammable gases!
Sparks may occur when using the HF device as directed.
►
Observe the safety guidelines in the instructions for use of the HF device.
WARNING
Burns due to tissue contact with non-insulated areas of the working tip outside
the coagulation site!
►
Avoid tissue contact with non-insulated areas of the working tip.
WARNING
Thermal injuries to patients/users due to insufficient insulation of leads in active
accessories!
►
Adjust the HF device to an appropriate setting to ensure that the peak output
voltage does match or not exceed the accessory voltage rating specified for
the product.
CAUTION
Damage to the working insert due to incorrect handling or operation! To avoid
damage to the working tip, especially to the ceramic insulation:
►
Apply caution when operating the product.
►
Do not apply excessive force.
►
Protect the working tip against knocks and impacts.
►
Use the pin protector when the product is not in use.
Product component
Number of reprocessing cycles
Working insert
4
Maximum 50 cycles
Insulating outer tube
5
450 cycles
Handle
A
20 cycles
CAUTION
Damage to handle A/sheath B or working insert due to incorrect handling!
►
When establishing the connection, do not hold the product at the insulating
outer tube when pushing the sheath into the handle as, otherwise, the outer
tube will be displaced.
►
Do not hold or pull at the moveable ring since, by doing so, the ball end of the
working insert could get bent.