LEVICS Instrument (92-950) and double tubing (700S0903-10) | Safety and Performance Information (MDR Annex I)

Safety
Before using the instrument, always observe the instructions for use of the
ultrasonic unit and the compatible accessories.
These instructions for use also describe the compatible sonotrodes and flues
(sonotrode set) and how to handle the compatible tubing.
Keep these instructions for use for future reference.

Intended use
Ultrasonic surgical devices for resection of tissue on humans.
The instrument is intended solely for use in spine surgery.
The instrument can be used for open and minimally invasive surgery.
Any non-intended use can have serious consequences.
A knife sonotrode is used for cutting the bone. A rasp sonotrode is used for
removing the bone.
The indications and contraindications, the clinical benefit, the effect and side
effects, the patient group and high-risk patients are determined using the
compatible sonotrode.

Indications
The instrument with the compatible sonotrode is used for the dissection of
bones, e.g., in the course of laminoplasty and laminectomy. Medical indications
include: spinal canal stenosis, spinal deformities, spinal trauma, ligament
hypertrophy and ossification, discopathy, spondylolisthesis.

Contraindications
Use on the central circulatory system or the central nervous system is absolutely
contraindicated. The treatment of high-risk patients is relatively contraindicated.
In these cases, the risks of the treatment must be weighed up against the
benefits particularly carefully taking into account individual medical and surgical
conditions.

Clinical benefit
Dissection or ablation of bones of the human spinal column for access or
decompression purposes.

Effect
The sonotrode and instrument are used for the selective dissection or removal
of bones. The flue covers the side of the sonotrode and ensures that irrigation
solution is directed to the sonotrode tip.

Side effects
The sonotrode tip heats up. Tissue is treated by targeted contact with the
sonotrode. Unintentional contact can cause unintended thermal damage to
tissue. The tissue absorbs ultrasonic energy or the cavitation effect spreads,
which can cause damage to deeper layers of tissue. The risk of injury to the
surrounding tissue due to scarring, e.g., of the dura mater spinalis, increases
with each treatment in the same area.

Patient group, high-risk patients
Anyone who is not a high-risk patient can be treated. The high-risk patient
group includes infants and children who are not yet 14 years old as well as
pregnant women and hemophilia patients. No definitive findings are available
for the treatment of high-risk patients. As the attending physician, you must
therefore particularly carefully weigh the risks of treating high-risk patients
against the benefits and decide individually about the use of the product.

Qualification
Only qualified and instructed physicians who have been trained in the intended
use may use the instrument to treat patients.
Only qualified specialist staff may use the instrument in the sterile and nonsterile
areas of the operating room to prepare and end the treatment, and to
support the surgical personnel during the treatment as well.
Reprocessing and maintenance may only be carried out by qualified specialist
staff that were assigned by the owner.

Risks
Device-related (e.g., malfunction, residues) and use-related events (e.g., use
error, abnormal use) may lead to risks: infection or cross-contamination (e.g.,
prions, aerosol), irritation, sensitization or inflammatory response, delay in
treatment, tissue damage or injury (e.g., in the area of the spinal column or the
spinal cord, due to scar formation in the case of revision surgery, high-risk
patient related, bleeding, burning).
Provide your patients with information about the risks and side effects related
to treatment.

Compatibility
The following are exclusively compatible: ultrasonic unit from Söring, knife and
rasp sonotrode set, LEVICS tubing, and LEVICS instrument tray (optional).

Application environment
Only medically used operating rooms. The atmosphere in the immediate vicinity
of the instrument may not be oxygen-enriched; there may be no flammable
substances and no danger of explosion or fire.
The instrument must not be used within the range of influence of magnetic or
electromagnetic fields. Electromagnetic fields such as those generated by an
MRI scanner can influence the function of the instrument or move the
instrument.

Personal protective equipment
Wear suitable protective equipment. This prevents infections and crosscontamination.
Protective clothing, eye protection, a face mask, and single-use
gloves are suitable.

Reprocessing prior to the first treatment
The instrument and new spare parts are non-sterile when shipped. For this
reason, all parts need to be sterilized by reprocessing prior to the first
treatment.
Single use articles that are supplied in sterile condition – the sonotrode set and
the tubing – may not be reprocessed.

Contaminated parts
Contaminated parts can infect everything that comes into contact with them.
For this reason, only use sterilized parts.
Observe the information on the packaging concerning the use-by date of the
parts. If the packaging is damaged, has been opened unintentionally, or has
been exposed to ambient conditions other than those specified, you must
reprocess the reusable parts. Single use articles must not be reprocessed, as
their sterility and function afterwards cannot be guaranteed. You must dispose
of single use articles.

Prions
The instrument is used in spine surgery. This exposes all parts to potential
contamination with pathogenic prions that can induce human transmissible
spongiform encephalopathy (TSE).

Irrigation
The instrument is only equipped with irrigation. The irrigation solution must be
aspirated. Do not set the irrigation capacity too high, because too much
irrigation solution impairs your view of the surgical site.

Irrigation solution
Physiological saline solution or Ringer's solution. Sufficient irrigation solution
must be used for treatment.

Bioaerosols
Aerosols are formed by the irrigation solution used during treatment. These
aerosols may contain infectious microorganisms.

Treatment duration
Uninterrupted use for less than 60 minutes.
Procedure time within an activation cycle:
- Ultrasonic: activated maximum 15 minutes (75%) followed by a minimum of
5 minutes not activated (25%).

Handling the instrument cable
The instrument cable must be in perfect condition. Do not kink or crush the
instrument cable to avoid damaging the insulation. An electric shock due to
damaged or cracked insulation on the instrument cable may result in serious
injury, burns, death, or fire.
During treatment, be aware of the position of the instrument cable and the
compatible tubing so that nobody stumbles over them, since the abrupt
movement upon stumbling can cause injuries to the patient. Fix the compatible
tubing to the instrument cable with the provided clips to avoid hindering
others.

High-frequency current
Do not apply high-frequency external voltage to the instrument or the
compatible single use articles.

Manipulation
The instrument and the compatible single use articles may not be manipulated.
Modifications or manipulation can have serious consequences.

Serious incidents
You must report serious incidents to the manufacturer and the responsible
authority.

Cybersecurity
Connection to or integration into a (medical) communication network is not
possible. Neither patient nor user data are saved.
You will find all further information in the instructions for use for the ultrasonic
unit.

Functionality
Instrument
The instrument generates a mechanical ultrasonic vibration that is transferred to
the sonotrode. While the instrument is activated, irrigation solution is routed to
the sonotrode.

Sonotrodes and flue (sonotrode set)
The ultrasonic vibration permits the ultrasonically-assisted dissection or removal
of tissue.
The flue directs the irrigation solution to the sonotrode tip in a controlled
manner, and protects the surrounding tissue against contact with the hot
sonotrode.
The torque wrench is used to assemble and disassemble compatible
sonotrodes. The torque wrench ensures that the sonotrode is tightened to the
required torque when assembled.

Tubing
Accessories for ultrasonic surgical devices for resection of tissue on humans.
The tubing conducts irrigation solution from the irrigation bottle to the
instrument.