Intended Use - Medax MEDONE Manual Del Usuario

m e d i c a l d e v i c e s

INTENDED USE

MEDONE biopsy system must be used for histological biopsy
of soft tissues.
It is not intended for use in bone biopsy.
INSTRUCTIONS FOR USE
Preliminary activity:
Using appropriate aseptic technique, remove the device

from its package.
Before using inspect the device to exclude the presence

of damaged tip, bent mandrel or other imperfections that
would prevent proper function. If the needle components
are damaged, do not use the device.
Disinfect the area of skin and proceed with administering an

adequate level of anaesthetic.
If necessary, use a scalpel to make a localized incision

into the skin area where puncture is to take place, in order
to facilitate access of the needle cannula.
Biopsy procedure:
Load the Medone biopsy system by pulling back the loading

lever located on the top of the handle:
1. the first click indicates the loading of the cannula (pulling back
the lever for withdraw the cannula and lock it on «load
position»);
2. the second click indicates the loading of the mandrel (pulling
back the lever for withdraw the mandrel and lock it on
«load position»).
Now the device is ready to be used.

Slowly insert the needle to reach the proximity of the lesion

to be biopsied.
When the needle is in the right position, maintaining

unchanged the needle orientation and the devices's
position, press one of the two fire button located either on
the side and on the back of the device.
In this way the mandrel and the cannula will advance
automatically.
Slowly draw out the needle from patient.


To remove the specimen reload the cannula by pulling back

the loading lever in order to withdraw the cannula and expose
the mandrel's notch.
Remove the specimen.

If additional biopsies of the same organ are required reload

the device by pulling back the loading lever, in order to
withdraw the mandrel and repeat the above described
procedure.
Warning: Before repeating the procedure make sure that
the needle has not been damaged during the biopsy
maneuvers (bending needle or damaged tip).
If you note the presence of damaged or imperfections of the
needle do not use the device.
Biopsy procedure with coaxial introducer needle:
The coaxial introducer needle must be used when multiple
biopsies of soft tissue are required.
Used with Medone biopsy needle allows multiple accesses to
the biopsy site with a single puncture causing less trauma to
the patient.
Slowly insert the coaxial introducer needle into the tissue up

to the biopsy area.
Remove the stylet.

Insert the Medone biopsy needle into the coaxial cannula

and proceed with the sampling (refer to the biopsy needle
instruction for use described in the previous section).
Remove the biopsy needle and insert it again to perform

multiple biopsies.
At the end of procedure, remove all devices and

accessories paying attention to the necessary precautions
for potentially contaminated materials.
Throw away after use and dispose together with hospital

waste following the laws in force.
LIMITATIONS AND WARNINGS
Usage allowed only by qualified physicians. MEDAX

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 the

device must be based on the clinical training of each
physician.
Never test the device by firing into the air. Damage may

occur to the needle or patient/user injury.
Before using, inspect the needle to exclude the presence of

damaged tip, bent mandrel or other imperfections that
would prevent proper function.
If the needle components are damaged or bent, do not use
the device.
Unusual resistance against the mandrel during the biopsy

maneuver may cause the mandrel to bend at the specimen
notch.
A bent specimen notch may interfere with the needle
function.
Non-pyrogenic, sterile device: not to be reused, resterilized or

reconditioned in any way.
Single-use/single-patient device: reuse of the device may

cause cross infection to patient and/or user.
Verify the integrity of the packaging and the validity of the

product before use.
The product must not be used if the package is unsealed,

damaged or wet.
Keep in a fresh and dry place, avoid exposure to light and

high temperature.
Do not use in magnetic resonance (MR) environment.

ENGLISH