LiNA SeaStar Bedienungsanleitung Seite 2

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REF: 4000-R-SL, 4000-R-VL, 4000-R-VS, 4000-R-SS, 4000-R-VV
Intended use:
The LiNA SeaStar™ is intended to retract soft tissue from the operative surface.
Patient population:
All groups dedicated to surgical procedures which require optimal exposure.
Device description:
The LiNA SeaStar™ is a retractor ring with grooves every 2,5 cm on the convex site. The hinges are controlled by finger
screws allowing the two ring halves to remain at any desired angle. The device is provided in a broad range of shapes
and sizes which can easily be adjusted to fit various anatomical areas, thereby facilitating different surgical applications.
The LiNA SeaStar™, together with LiNA Skin Hook™ is a complete system for retracting delicate soft tissue. The flexible
design of the system allows easy adjustment and repositioning of the LiNA SeaStar™ during the surgical procedures
and provides optimal exposure of the surgical site.
Precautions:
• Use of the LiNA SeaStar™ requires adequate training and experience in performing surgical procedures. Intended
user profile is a trained surgeon or physician.
• Some accessories used with the LiNA SeaStar™ (e.g. LiNA Skin Hook™) are single use materials. Single use accessories
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used with the reusable instruments should be discarded after use.
• Do not use excessive force during the screw tightening.
• Non-sterile, steam-sterilize before the first and each consecutive use on patients.
• No modification of this equipment is allowed.
• The number of times the device is exposed to autoclaving must not exceed 100. If any errors are detected prior to this
amount, dispose of the device in accordance with hospital, administrative and/or local government policy.
Warnings:
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• Do not use past expiration date.
• Carefully inspect the device for any damage prior to use. Dispose of the device if bent, malformed or if breaks or
cracks are found.
Important information:
The following instructions apply exclusively to the reusable retractor rings. The disposable retractor rings by
LiNA Medical may not be sterilized. Please follow the instructions on mechanical cleaning of the instruments. The
instruments are to be handled with care, e.g. do not drop them on the floor. Avoid putting loads on the instruments
or bending them. In order to avoid damage to the instruments, do not use metal brushes, metal sponges or the like.
Use cleansers and/or disinfectant with a pH range between 4.5 and 12. Follow the manufacturer's instructions
regarding dosage, application time and replacement of the solution.
Instruction for use:
When using for the first time:
Take the instruments out of the packaging and remove the protective wrapping.
Preliminary cleaning:
Preliminary cleaning can be omitted if the instrument had contact exclusively with healthy and intact skin.
Ultrasonic cleaning:
Open and disassemble the instrument. Place instrument parts in the basket avoiding overlap. Add cleaning agent to
the water and set the temperature of the solution according to the instructions of the cleaning agent manufacturer.
Cleaning with the ultrasonic cleanser at 35 to 40 kHz takes 5 minutes. Rinse instruments with water and afterwards
immediately begin with the cleaning and/or disinfecting procedure.
Cleaning and disinfection:
If possible, always choose mechanical cleaning over manual cleaning. Cleaning solutions and disinfectants are to be
replaced if they become contaminated and should be replaced at least once per day.
Manual cleaning:
Use synthetic brushes, water jet pistols or lent-free towels and fresh non-adhesive cleaning agents for manual cleaning.
Rinse thoroughly with desalinated water. Place instruments in disinfectant and afterwards use a suitable cleaning
agent as described above. Rinse the instruments again with desalinated water and then dry them.
Automatic cleaning and disinfecting device:
Chemically clean at 40 to 60 degrees Celsius after the pre-rinse. Residue from the procedure is to be removed carefully
in the 2nd rinse phase. Avoid deformations resulting from neutralization agents. Disinfect the instrument parts
x 100
thermally at 80 to 95 degrees Celsius. Rinse with desalinated water and then let dry.
2020-10 FV0056M
LiNA SeaStar™ LiNA SeaStar™
REF: 4000-R-SL, 4000-R-VL, 4000-R-VS, 4000-R-SS, 4000-R-VV
Drying:
The instruments can be dried in a drying oven or with pressurized air.
Inspection and check:
Allow the instruments to cool down to room temperature and macroscopically check them for residue and
contamination. Instruments that are not free from residue must undergo the entire cleaning procedure again.
Check the instruments to see if they function as intended. Deformed, damaged or non-functioning instruments may
not be used again and must be discarded.
Packaging:
Use packaging material that is suitable for the instruments and which protects against microbiological contamination
during storage.
Sterilization:
Steam sterilization of the instruments is mandatory. Packaging and storage material must be adapted to the
instruments and the sterilization procedure.
Steam sterilization:
Place instruments into the baskets making sure that the recommended total weight is not exceeded. It is recommended
to store the baskets in towels or fleece and in the appropriate containers. The baskets can also be alternatively placed in
paper bags. Autoclave between 3 and 18 minutes at 134 degrees Celsius or between 15 and 30 minutes at 121 degrees
Celsius. After autoclaving, dry and let cool to room temperature (23 degrees Celsius, +/- 2 degrees).
Description of use:
Place the LiNA SeaStar™ around the initial incision and insert the hooks in directly opposing quadrants with equal
tension. As dissection progresses, move the position of the hook into the deeper layers of the fascia. You may then
add new hooks or reposition those already in place to achieve full balanced retraction from any angle. To ease closing
maintain constant opposing tension.
Storage:
Sterilized instruments must be stored in dry, dust-free and ventilated rooms without corrosive vapors.
Additional information:
Employees must be trained in the sterilization of instruments. The autoclaves must comply with ISO 17665.
Washing and disinfectant systems must be approved in accordance with ISO 15833. The packaging material for the
sterile equipment must comply with the ISO 11607 standard. The instructions listed above have been tested by the
manufacturer and are suitable for sterilizing SeaStar reusable retractor rings. It is the responsibility of the person in
charge of sterilization to ensure that only material, equipment and staff which lead to the desired result are deployed.
This includes acceptance and regular routine checks of the process.
Reporting:
Any serious incident that has occurred in relation to the device should be reported to the LiNA Medical ApS and the
competent regulatory authority of the country in which the user and/or patient is established.
Caution:
Federal Law (USA) restricts this device to sale by or on the order of a trained physician.
Country of origin: Poland.
CE marking 2007.
LiNA Medical ApS - Formervangen 5 - DK-2600 Glostrup - DENMARK - Tel: +45 4329 6666 - Fax: +45 4329 6699 - e-mail: info@lina-medical.com - www.lina-medical.com
LiNA is a registered trademark of LiNA Medical in EU, US and CN
en
2020-10 FV0056M