Device Description; Indications For Use - Merit Medical TEMNO A.C.T Gebrauchsanweisung

Biopsy System

DEVICE DESCRIPTION

The TEMNO™ A.C.T. Biopsy System is a single patient use core
biopsy device. It is available in several needle gauge sizes
and lengths. The plunger is color coded according to the
various gauge sizes (e.g., gray=22G, green=20G, orange=18G,
white=14G).

INDICATIONS FOR USE

Intended for use in obtaining core biopsy samples from soft
tissue such as breast, kidney, liver, lung, thyroid, and various
soft tissue masses. Not intended for use in bone.
STEP 1: COAXIAL TEMNO PLACEMENT
During the pre-procedure set-up, insert the biopsy device
through the coaxial introducer needle to verify compatibility.
Adjust sliding stopper on coaxial needle to desired calibration
level. Lock in place. Insert coaxial and stylet until sliding stopper
rests on skin surface. Image coaxial needle to make sure the tip
is proximal to the lesion. Remove inner stylet.
1.
STEP 2: SAMPLE NOTCH SIZE
Select sample notch size by turning the white coaxial bolt
on the Temno Biopsy Needle from a maximum of 19 mm
to a minimum of 9 mm as shown by the indicator window.
The amount of sampling notch exposure and needle
advancement are measured from the distal end of the coaxial
introducer.
2.
STEP 3: TEMNO NEEDLE SPRING CHARGE
1.
Charge Temno needle by pulling back hard on the plunger
1.
until a firm click is felt indicating that the needle spring is
charged.
3.
2.
STEP 4: TEMNO NEEDLE PLACEMENT
With the needle stylet fully retracted, insert the Temno
2.
needle into the coaxial introducer and gently connect the
coaxial's hub onto the Temno's white coaxial bolt until snug.
3.
3.
5.
I N S T R U C T I O N S F O R U S E
2
English