Contraindications; Potential Complications; Equipment Required - Merit Medical TEMNO Elite Mode D'emploi

CONTRAINDICATIONS

The TEMNO Elite biopsy system: Good medical judgement should be exercised in
considering biopsy on patients who are receiving anticoagulant therapy or who have a
bleeding disorder.
WARNINGS
1. Post-biopsy patient care may vary with the biopsy technique utilized and the individual
patient's physiological condition. Observation of vital signs and other precautions
should be taken to avoid and/or treat potential complications that may be associated
with biopsy procedures.
2. The collection of multiple core biopsy samples may help to ensure the detection of any
cancer tissue. A "negative" biopsy in the presence of suspicious radiographic findings
does not preclude the presence of carcinoma.
NOTE: Inspect the TEMNO Elite biopsy system, Valved Coaxial Introducer Needle,
or Standard Coaxial Introducer Needle for damaged point, bent shaft, or other
imperfections prior to use and after each sample is collected.
DO NOT USE the device if any imperfection is noted.
NOTE: After use, the TEMNO Elite biopsy system, Valved Coaxial Introducer Needle, or
Standard Coaxial Introducer Needle may be a potential biohazard. Handle and dispose
of in accordance with acceptable medical practice and applicable local, state, and federal
laws and regulations.
3. In EU, any serious incident that has occurred in relation to the device should be
reported to the manufacturer and the competent authority of the applicable member
state.
PRECAUTIONS
1. The TEMNO Elite biopsy system, Valved Coaxial Introducer Needle, and Standard
Coaxial Introducer Needle should be used by a physician who is completely familiar
with the indications, contraindications, limitations, typical findings, and possible side
effects of core needle biopsy.
2. The introduction of the needle into the body should be carried out under imaging
guidance, ultrasound, x-ray, CT, etc.
NOTE: This product has not been tested for MRI imaging compatibility.
3. Never test the TEMNO Elite biopsy system by firing into the air. Damage may occur to
the needle/cannula tip and could result in patient and/or user injury.
4. Unusual force applied to the TEMNO Elite Biopsy System stylet while extended out of
the supportive cannula may cause the stylet to bend at the specimen notch. A bent
specimen notch may interfere with needle function.
5. For single patient use only. Do not reuse, reprocess or resterilize. Reuse, reprocessing
or resterilization may compromise the structural integrity of the device and/or lead
to device failure which, in turn, may result in patient injury, illness or death. Reuse,
reprocessing or resterilization may also create a risk of contamination of the device
and/or cause patient infection or cross-infection, including, but not limited to, the
transmission of infectious disease(s) from one patient to another. Contamination of the
device may lead to injury, illness or death of the patient.

POTENTIAL COMPLICATIONS

Potential complications associated with core biopsy procedures and coaxial guided biopsy
procedures are site specific and may include but are not limited to: hematoma; hemorrhage;
infection; adjacent tissue injury; pain; bleeding; hemoptysis; hemothorax; foreign body
non-vascular; inflammatory reaction; non-target tissue, organ or vessel perforation;
pneumothorax; track seeding; and air embolism. Air embolism is a rare but serious potential
complication of lung biopsy procedures. Rapid deterioration of neurological status and/or
cardiac arrhythmia may be indicative of air embolism. Prompt diagnosis and treatment must
be considered if the patient exhibits signs or symptoms of air embolism.

EQUIPMENT REQUIRED

1. Appropriate imaging modality
2. Surgical gloves and drapes
3. Local anesthetic
4. TEMNO Elite Biopsy System
5. Valved or Standard Coaxial Introducer Needle (optional)
6. Sample collection container
7. Other equipment as necessary
DIRECTIONS FOR USE FOR TEMNO ELITE BIOPSY SYSTEM
1. Using aseptic technique, remove the instrument from its package.
2. Remove the protective needle sheath
3. Before using the TEMNO Elite biopsy system, inspect the needle for damaged point,
bent shaft, or other imperfections that would prevent proper function. If the needle is
damaged or bent; DO NOT USE.
4. Energize or arm the instrument by pulling back on the plunger to withdraw the cannula
and inner stylet and lock the cannula in place. The instrument can be energized to one
of two penetration depths. Pulling the plunger to the first stop, indicated by a firm click,
sets the device penetration depth to 10mm. Pulling the plunger farther back to the
second stop, indicated by a firm click, sets the penetration depth to 20mm See Figure
4.
Figure 4: Plunger retracted to energize (cock) Instrument
First stop: 10mm
BIOPSY PROCEDURE FOR THE TEMNO ELITE BIOPSY SYSTEM
The biopsy procedure must be performed using appropriate aseptic techniques.
1. Prepare site as required. Adequate anesthesia should be administered prior to
procedure.
2. For ease of insertion, puncture the skin with a scalpel at the entry site (OPTIONAL)
3. Verify the instrument is energized (armed) by looking at the penetration depth
indicator and confirming either a "10" or "20" is visible. See Figure 5.
4. With the inner stylet fully retracted so that the sample notch is covered by the cannula,
insert the tip of needle to the point to be biopsied. DO NOT advance the inner stylet by
pressing on the plunger until the instrument is in position.
5. Press the plunger to advance the inner stylet (i.e. sample notch) into tissue. At the end
of the advancement the plunger will encounter a stop and the fire ready indicator will
form a solid line. See Figure 5. With imaging verify the sample notch is in the target
area to be biopsied.
6. Fire the cutting cannula by depressing the plunger past the fire ready indicator to
capture the biopsy specimen in the sample notch.
7. Remove the needle from the patient and pull the plunger back to acquire the biopsy
specimen. Gently advance the plunger forward to expose the biopsy specimen. DO
NOT press the plunger past the fire ready indicator during this step.
8. (Optional) Push the Sample Assist™ forward for assistance with removing the sample
from the notch.
or
Penetration Depths
Second stop: 20mm