Medtronic Signia Stapler User Manual

THE FUTURE
OF STAPLING IS
IN YOUR HANDS.

TO D AY.

The world’s rst smart stapler

Signia™ Stapler
Product Information Guide

TABLE OF

CONTENTS

PRODUCT OVERVIEW 03

Technology Overview

 Features&Benets

PRODUCT COMPARISON 09

MATERIALS MANAGEMENT 10

Instructions For Use
Cleaning, Sterilization & Storage
Ordering Information

Introduction

510(K) Clearance

AN INTELLIGENT
TOOL FOR

HANDS

THAT HEAL.

Smart technology that provides real-time feedback
and powered rotation, articulation, and ring — with one hand.
That’s the Signia™ stapler.

Your hands and your expertise. They’re among your most important tools in the OR. And our new stapler
is designed to be the ultimate complement — by providing you real-time feedback and staple line
consistency in a true one-handed design.

™

The Signia

■ Fully powered articulation, rotation, clamping,

andring,whichprovidesgreaterprecisionand

maneuverability compared to manual staplers

■ Push-buttonpoweredringthatdecreasesthe
strain of operation when stapling, compared to

ringmanually

And that’s just the beginning.

3

stapler gives you:

4

1

1,2,3

■ Compatibility with our existing reload portfolio
featuring the proven performance of

1,4

Tri-Staple

■ Enhanced performance when paired with
Tri-Staple
with Tri-Staple™ 2.0 cartridges

™

technology

™

2.0 reloads and Signia™ loading units

A POWERED
STAPLER

THAT
EMPOWERS

YOU.

All the information you need at your ngertips

To help you deliver consistent staple lines, the Signia™ stapler is equipped with state-of-the-art

technologythatautomaticallyadjustsclampforceandringspeed.

to you in real-time on an easy-to-understand display screen1 right on the stapler.

How it works

The smart features of the Signia™ stapler are only available when it’s paired with Tri-Staple™ 2.0
reloads and Signia™ loading units with Tri-Staple™ 2.0 cartridges. That’s because our new loading units
have a chip which allow them to communicate meaningful information to the stapler — during your
procedure.

4

1

2,3

This information is provided

NOT ALL
TISSUE IS

CREATED
EQUAL

Evidenceshowsringmoreslowlyinthicker

tissue helps ensure a higher percentage of
properly formed B-shaped staples.

2

Malformed Staple % In Variable Tissue vs. Firing Speed

Malformed Staple Percentages (per ring)

0% 3% 25%

0% 0% 8%

0% 0% 4%

INCREASING SPEED DURING FIRE

INCREASING TISSUE THICKNESS

†,2

Adaptive Firing™ Technology

It’s what makes the Signia™ stapler smart. And it’s
what gives you real-time feedback when clamping

onandringthroughtissue.5

With Adaptive Firing™ technology, we’re putting the
tactile feedback of a manual stapler into a visual
display on a powered device — and we’re taking it to
the next level.††

That’s because Adaptive Firing™ technology:

■ Measures force and provides feedback when
clamping tissue

■ Setsringspeedbasedonclampforce
measurement

■ Continuouslymeasuresforceduringring

andslowsringspeedbasedonthose

measurements

1,2,3

6

6

Three force zones with one objective: consistent staple lines

Not only does the Signia™ stapler measure force and adjust

ringspeed,itletsyouknowwhenitdoes—withvisualandaudible

feedback.6

Note: Display feedback provided when using the Signia™ stapler with Tri-Staple™ 2.0
specialty reloads or Signia™ loading units with Tri-Staple™ 2.0 single use cartridges

Signia™ Stapler Operational Use Display Screen Sequence

Zone 1:

Indicates the
stapler will start

ringatitsregular

speed to deliver
optimal staple
formation

6

Zone 2:

Indicates the
stapler will require

ahigherringforce

due to thicker or
variable tissue and
the device will slow
its speed to deliver
optimal staple
formation

6

Zone 3:

Indicates the stapler
will require the

highestringforce

due to very thick or
variable tissue and
the device will adjust
to its slowest speed
to deliver optimal
staple formation

1,2,3

6

†N=243rings.Graphrepresentsvaluesbasedonpreliminaryexvivoporcine

model data. Represents the various speeds a user can deploy staples using a

manualhandle.Thisdatawasusedtodeveloptheoptimalringspeedsforthe

Signia™ System.

†† SAGES Lap Report. Engineering Report Number RE00055515

5

POWERED
ROTATION,
ARTICULATION,
& FIRING.

WITH ONE HAND.

1

Every piece of the Signia™ stapler is designed
to benet to you and your patients

■ Single-handed operation means your other hand is freed to focus
on the surgical site

■ Push-buttonpoweredringreducesstrainofoperationcompared

toringmanually

■ Enhanced ergonomics create a well-balanced feel
in the hand during use

■ Easy-to-reach controls accommodate a range
of hand sizes1

■ Easy-to-understand display screen1

The Tri-Staple™ technology advantage

Benetsyou—andyourpatients—cancounton.TheSignia™ stapler delivers

them with the unparalleled performance of Tri-Staple™ technology, which:

Generates
less stress on
tissue during
compression and
clamping

7

1

4

1

Allows greater
perfusion into the
staple line

Delivers

8

outstanding
performance in
variable tissue
thicknesses

6

FLEXIBILITY
& COMPATIBILITY

WITHIN YOUR
REACH.

Our fully reposable platform oers:

■ Pricingexibility

■ Signia

■ Signia

The system is comprised of:

■ Signia™ power handle

■ Signia

■ Signia

™

power handle can be reused

™

linear adapter can be reused

™

power shell

™

adapters

■ Various accessories*

And it’s compatible with:

■ Tri-Staple™ 2.0 reloads

■ Signia

■ Endo GIA

■ Endo GIA

*System accessories include a single-bay battery charging station, reusable
insertion guide, and a manual retraction tool.

™

loading units with Tri-Staple™ 2.0 cartridges

™

reloads

™

reloads with Tri-staple™ technology

7

Signia™ Power Handle

The Signia™ power handle is a reusable
handheld battery-powered stapling
handle. It includes a microprocessor,
electronics, motors, a LCD display screen,
and rechargeable lithium-ion batteries in a
sealed packet.
NOTE: The power handle is a nonsterilized
device that deactivates after reaching the
end of its service life. It will not deactivate
while in use.

Signia™ Power Shell

The Signia™ power shell is a single-use,
sterile control shell that covers and seals the
non-sterile Signia™ power handle to create a
sterile barrier, control interface, and universal
adapter connection. It also provides a
communications interface for
Tri-Staple™ 2.0 single use reloads indicated
for use with the stapler.
Precaution: The power shell is
single-use only.

Signia™ Linear Adapters

The Signia™ linear adapters are reusable
instruments that connect with the
assembled Signia™ power shell and power
handle to enable functionality of compatible
Medtronic stapling reloads. The adapters
are composed of motormating connectors,
sensor gauges, and device communications
interfaces to provide communications
between Signia™ loading units with
Tri-Staple™ 2.0 cartridges, Tri-Staple™ 2.0
reloads, and the power handle.
It is provided nonsterile and must be
sterilized before use.
NOTE: The linear adapters are reusable
devices that deactivate after reaching
the end of their service life. They will not
deactivate while in use.

™

Reusable Insertion Guide

Signia

The reusable insertion guide is used to help
maintain the sterility of the Signia™ power
shell during insertion of the nonsterile Sig­nia™ power handle. It is provided nonsterile
and must be sterilized prior to each use.

8

Signia™ Manual Retraction Tool

The Signia™ manual retraction tool is a
reusable, handheld device that can be used

Single-Bay Charger

The single-bay charger and power supply

charges the power handle.
to operate adapter controls in the event the
stapler malfunctions during operation. The

toolcanbeusedtocompletearing,retract

the knife and open the jaws, and/or articulate
a stapling reload. It is provided nonsterile and
must be sterilized before use.

Non-Sterile Central Sterile Disposable

COMPETITIVE

COMPARISON

FEATURE SIGNIA™ STAPLER

Compatible with Signia™
loading units and Tri-Staple™

2.0 cartridges and reloads

Single, powered handle
compatible with 30 mm,
45 mm, and 60 mm reloads

Compatible with Endo GIA
reloads with Tri-Staple™
technology

Extra-thick reload with tissue
indications up to 3 mm

Integrated real-time feedback
display

Features Adaptive Firing
technology

Power source Lithium ion, 14.8 V, 2150 mAh 4 single-use batteries per

Reusability Reusable, reposable system

™

™

comprised of disposable and
reusable components

■

■

■

■

■

■

EES ECHELON FLEX™*
POWERED STAPLER

— —

— —

— —

— —

— —

— —

handle, single use, disposable

Single use, disposable Single use, disposable

EES ECHELON FLEX

™*

Points of articulation with the
45-degree maximum range

Articulation Powered Manual; second instrument or

Rotation Powered and manual Manual only Manual only

Clamping Powered Manual only Manual only

Firing Powered Powered Manual only

Jaw Opening Powered Manual only Manual only

Unlimited 3 on each side (left, right) 3 on each side (left, right)

Manual; second instrument or
lateral pressure against body
structure

lateral pressure against body

structure

9