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INTENDED USE
MEDONE ULTRA biopsy system has been designed to be
used for histological biopsy of soft tissues (such as breast,
kidney, liver, prostate and various soft tissue masses).
It is not intended for use in bone biopsy.
Warning: Test the device by firing into the air may damage
the sharpening of the cannula and/or the mandrel tip. Do
not keep fingers or other objects in front of the device as
the needle will advance 2.5cm rapidly, during activation.
INSTRUCTIONS FOR USE
Preliminary activity:
Using appropriate aseptic technique, remove the device from
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its package and prepare the biopsy site.
Disinfect the skin and proceed with administering an
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adequate level of anaesthetic.
If necessary, use a scalpel to make a localized incision
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into the skin, in order to facilitate access of the needle
cannula.
Step 1: Preparation of Medone Ultra biopsy
system
Load the Medone Ultra biopsy sytem by pulling back the
loading levers to the end of the stroke and release twice;
the first time to load the cutting cannula, the second time to
load the mandrel.
Step 2: Positioning of the Needle
Position the needle tip at or near the lesion to be biopsied.
It is recommended to use image guidance systems to reach
the desired area.
Step 3: Fire the Biopsy System
Two firing sequence methods are available once the biopsy
system is loaded:
1. Delayed Mode (semiautomatic method) - By pressing the
D button , the mandrel will trip and advance in the
sampling area. The operator use this delay firing method
to verify the position of the biopsy notch in the target area
prior to pressing the A button.
Pressing button A activates the cannula that advances,
cutting and capturing the specimen in the biopsy notch.
2. Automatic mode - The operator can choose to use the
fully automatic method, by simply pressing button A first.
In this way mandrel and cannula will advance
automatically in sequence for the collection and capture
of the specimen.
A = Automatic Mode
D = Delayed Mode (Mandrel only)
Step 4: Biopsy Specimen
To retrieve the collected tissue sample, hold the device with
the A and D firing buttons facing up and pull back and
release completely the loading levers once. This action will
retract the cannula exposing the mandrel biopsy notch
containing the specimen.
Step 5: Multiple sampling
After the tissue sample is removed from the biopsy notch,
additional tissue samples from the same patient may be
obtained.
Pull back the loading levers a second time to retract the
mandrel within the cannula and to make the device ready
for use again. Repeat Steps 3 to 5.
In the automatic mode, the Medone Ultra biopsy system is
designed to fire mandrel and cannula in rapid succession.
Please exercise caution before proceeding as the device
will advance 2.5 cm at the time of activation.
Biopsy procedure with coaxial introducer needle:
1. Remove protective coaxial introducer needle cap.
2. Slowly insert the coaxial introducer needle into the tissue
up to reach the proximity of the biopsy area or the
proximity of tissues at risk of injuries.
3. Remove the mandrel by turning the handle counter-
clockwise.
4. NOTE: Model provided of additional blunt tip stylet
In case the zone under examination is found to be close to a
critical area (arteries, veins, internal organs, etc.) it is
possible to use a special atraumatic blunt tip stylet in order
to reduce the risks of involuntary damaging of such areas.
After having removed the trocar tip mandrel, insert the
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additional blunt tip stylet into the coaxial cannula and turn
it clockwise to engage with the coaxial needle cannula
hub. Proceed with the penetration to the margins of the
lesion that will be submitted to biopsy evaluation.
Remove the blunt tip stylet by turning the handle counter-
·
clockwise.
5. Insert the previously charged Medone Ultra biopsy
system inside the coaxial cannula and proceed to the
sample collection (refer to the biopsy system instruction
for use described in the previous section).
6. Remove the Medone Ultra biopsy system and insert it
again to perform multiple biopsies.
7. At the end of procedure, remove all devices and
accessories paying attention to the necessary
precautions for potentially contaminated materials.
8. Throw away after the use and discharge together with the
hospital waste following, the laws in force.
LIMITATIONS AND WARNINGS
Usage allowed only to qualified physicians. MEDAX
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declines every responsibility for damages caused to the
patient when the device is used in an improper way, with
wrong maneuvers or if handled by non qualified
personnel.
The procedure described is for guidance only: the use of
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the device must be based on the clinical training of each
physician.
Before using, inspect the needle to exclude the presence
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of damaged tip, bending or other imperfections that would
prevent proper function. If not, do not use the device.
Unusual resistance against the mandrel during the biopsy
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maneuver may cause the mandrel to bend at the specimen
notch and thus interfere with the needle function.
The device is sterilized by ethylene oxide and not to be
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resterilized or reconditioned in any way.
Single-use/single-patient device: re-use of the device may
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cause cross infection to patient and/or user.
Verify the validity of the product before use.
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The product must not be used if the package is unsealed,
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damaged or wet.
Keep in a fresh and dry place, avoid the exposure to light
·
and high temperature.
Do not use in magnetic resonance (MR) environment.
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