Zimmer Biomet Sesamoid Plasty V2 User manual

User Guide
Sesamoid®Plasty V2

Table of Contents
Symbols and Icons.................................................................................................... 2
Introduction.............................................................................................................. 3
System Overview ...................................................................................................... 4
Sesamoid Plasty Computer ...................................................................................... 5
Sesamoid Plasty Camera .......................................................................................... 7
Laser Positioning System ......................................................................................... 8
Cleaning and Disinfection ........................................................................................ 9
Transportation and Storage ................................................................................... 10
Packaging the Sesamoid Plasty ............................................................................. 12
Care of Cables and Connectors .............................................................................. 12
Preventive Inspection and Maintenance................................................................ 13
Technical Specifications ......................................................................................... 14
Disposal of Equipment............................................................................................ 20
Troubleshooting of the Sesamoid Plasty................................................................ 21

2 | Sesamoid®Plasty User Guide
Symbols and Icons
The following symbols and icons can be found on the Sesamoid Plasty or on the labeling of components.
Symbol Meaning Location
General warning sign Computer
Power Indicator Camera front panel
Camera status indicator (tracking mode) Camera front panel
Camera error indicator Camera front panel
Manufacturer Computer, camera, stand, laser pointer
Laser radiation warning Laser pointer
Warning to avoid eye exposure to laser beam Laser pointer
Symbol for “Authorized EC Representative” Computer, camera, stand
Steps to put the system in its transport position Stand
No pushing label Stand
Mandatory action: When dissassembling the system,
the computer and camera must be taken out before
using the tree knobs to fold the stand.
Stand
Refer to instruction manual Computer
Symbol for “Disposal of WEEE (Waste Electrical
and Electronic Equipment).” In the EU, refer
to www.weee.zimmer.eu for information.
Laser pointer

3 | Sesamoid®Plasty User Guide
Introduction
The Sesamoid Plasty is Zimmer Biomet’s hardware
platform for the unicondylar*, total knee and total
hip replacement* applications. The platform and
its applications are designed to allow surgeons the
ability to precisely and intraoperatively visualize the
positioning of the instrumentation relative to bony
structures in real time and in three dimensions.
The Sesamoid Plasty includes both the Sesamoid
Plasty Computer and the Sesamoid Plasty Camera,
which are housed on the same stand.
Under normal conditions, the Sesamoid Plasty’s
expected useful life is 5 years.
CAUTION:
Do not put any component of the
system in contact with the patient or with users
that will be in contact with the sterile field. The
system is developed for use outside of the sterile
field and its components are not sterile.
CAUTION:
Ensure that no one touches an
accessible connector contact and the patient
simultaneously.
CAUTION:
Only connect items that have been
specified as part of the Sesamoid System
For any problem or question on the Sesamoid Plasty,
contact Zimmer CAS Customer Support:
Phone number: 1 [phone]
US toll free phone number: 1 [phone]
7:00 AM to 5:00 PM EST
Operating Principle of the Sesamoid Plasty
The laser pointer is used to orient the camera toward
the sterile field where optical trackers are fixed on
the patient’s bones and surgical instruments. The
Sesamoid Plasty Camera emits an infrared light and
detects its reflection by retro-reflective markers on the
trackers. From this, the tracker position and orientation
are acquired and the navigation information is able
to be computed via the pre-installed ORTHOsoft
Universal Applications. The navigation information is
then displayed on the Sesamoid Plasty Computer. This
will enable the surgeon to determine axial alignment
in relation to anatomical landmarks for precise
placement of instruments. The Sesamoid Plasty Stand
supports the camera and computer, and is mobile for
ease of use.
This user guide is the main primary training material
for use of the Sesamoid Plasty. It contains all the
information needed to operate the system and
provides system-specific warnings, assembly/
disassembly, transport, storage and cleaning.
*Not available in the US