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Biopsy Needles
CAUTION: Federal (U.S.A.) law restricts this device to sale by or on the order of
a physician.
DEVICE DESCRIPTION
The TEMNO Elite™ biopsy system is a single use Total 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., yellow=20G, pink=18G, purple=16G, green=14G, and blue=12G).
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As packaged, protective needle sheath not shown
1. Plunger: Used to energize (arm), advance the sample notch, and fire the cutting
cannula.
2. Fire ready indicator: When line is solid, indicates sample notch has been fully advanced
and biopsy device is ready to be fired.
3. Centimeter Markings
4. Echogenic Surfaces
5. Sample Assist
TM
6. Penetration depth indicator
a. Not energized: 0
b. Energized (armed) to 10mm penetration depth: 10
c. Energized (armed) to 20mm penetration depth: 20
7. 10mm adapter (optional)
The TEMNO Elite biopsy system includes a biopsy device and has the option of including
a compatible Valved Coaxial Introducer Needle, or a Standard Coaxial Introducer Needle.
a. The Valved Coaxial Introducer Needle consists of an outer cannula with an attached
female luer-style lock hub with valve, an inner trocar stylet with an attached male luer-
style lock hub, and a slip ring style depth stop.
i. The Valved Coaxial Introducer Needle is designed for use with the TEMNO Elite
Biopsy System.
b. The Standard Coaxial Introducer Needle consists of an outer cannula with an attached
female luer-style lock hub, an inner trocar stylet with an attached male luer-style lock hub,
and a slip ring style depth stop.
i. The Standard Coaxial Introducer Needle is designed for use with the TEMNO Elite
Biopsy System.
c. The depth stop on both the Valved Coaxial Introducer Needle and the Standard Coaxial
Introducer Needle is color coded to match the gauge size of the TEMNO Elite biopsy
system (e.g., yellow=20G, pink=18G, purple=16G, green=14G, and blue=12G). The outer
cannula is only one-gauge size larger than the appropriate TEMNO Elite Biopsy System
(e.g., 19G Valved Coaxial Introducer Needle for a 20G TEMNO Elite Biopsy System).
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As packaged, protective needle sheath not shown
1. Trocar Stylet
2. Coaxial Cannula
3. Centimeter Marks
4. Depth Stop
5. Valve
As packaged, protective needle sheath not shown
1. Trocar Stylet
2. Coaxial Cannula
3. Centimeter Marks
4. Depth Stop
HOW SUPPLIED
The product is supplied sterile unless the package has been opened or damaged. Sterilized
using Ethylene Oxide. For single patient use only. Do not reuse. Do not resterilize.
INDICATIONS FOR USE/CLINICAL BENEFIT
The TEMNO Elite biopsy system is intended for use in obtaining biopsies from soft tissues
such as liver, kidney, breast, prostate, spleen, lung, lymph nodes, thyroid, and various soft
tissue masses. It is NOT intended for use in bone.
The Valved Coaxial Introducer Needle and Standard Coaxial Introducer Needle are intended
for use as a guiding needle in obtaining core biopsy samples from soft tissue such as liver,
kidney, breast, prostate, spleen, lung, lymph nodes, thyroid, and various soft tissue masses.
It is NOT intended for use in bone.
I N S T R U C T I O N S F O R U S E
Figure 1: TEMNO Elite Biopsy System
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- optional feature for sample core retrieval
Figure 2: Valved Coaxial Introducer Needle
Figure 3: Standard Coaxial Introducer Needle
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