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Zimmer Biomet Sesamoid Plasty V2, User Manual, Page: 3 / 24

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Zimmer Biomet Sesamoid Plasty V2 User Manual Download Page 3

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

Summary of Contents for Sesamoid Plasty V2

Page 1: ...User Guide Sesamoid Plasty V2 ...

Page 2: ......

Page 3: ...id 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 ...

Page 4: ...nd 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 Refe...

Page 5: ...or any problem or question on the Sesamoid Plasty contact Zimmer CAS Customer Support Phone number 1 514 395 8883 US toll free phone number 1 866 336 7846 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...

Page 6: ...sty Assemblies and Accessories Computer kit Camera kit Stand LEMO Cable Computer power cable HDMI cable optional Ethernet cable CAUTION It is recommended that if the Sesamoid Plasty is used with any configuration other than that shipped by Zimmer Biomet users should verify compliance with General Requirements for Basic Safety and Essential Performance for Medical Devices IEC 60601 1 ...

Page 7: ...do not use CAUTION Do not remove the caps on the serial ports callout 8 in Figure 2 for safety reasons these ports are not to be used CAUTION Never disconnect the three permanent connections at the bottom panel of the Sesamoid Plasty Computer Connections Only use the HDMI cable provided by Zimmer Biomet to connect the Sesamoid Plasty to an external display Only use the Ethernet cable provided by Z...

Page 8: ...from overheating Do not block the openings CAUTION If one of the following situations arise get the equipment checked by service personnel The power cord or plug is damaged Liquid has entered the equipment The equipment has been exposed to moisture The equipment does not work well or you cannot get it to work according to the user s manual The equipment has been dropped and damaged The equipment h...

Page 9: ... to infrared signals if they are in the same frequency range i e pulse oximeters The standard precaution is to shield these devices from the infrared light of the camera The user manuals of these devices should be consulted for specific instructions on how to reduce the chances of interference The presence of strong infrared sources including some lighting systems or infrared reflectors in the vic...

Page 10: ... 5V LR1 or type N alkaline batteries in the laser pointer The batteries provided with the laser pointer do not contain lead To change the batteries 1 Unscrew the laser pointer shell assembly 2 Take out the batteries 3 Insert new 1 5V N alkaline batteries taking into account the polarity of the batteries and the shell 4 Screw down the laser pointer The batteries should be disposed of per appropriat...

Page 11: ... clean with a damp cloth and mild detergent and then rubbed down with a dry woolen cloth Never use corrosive cleaning agents solvents or abrasive detergents or polishes If you are uncertain of the nature of a cleaning agent do not use it Do not use abrasive polishes Disinfection All parts of the equipment including accessories and connecting cables can be disinfected by wiping them with a cloth da...

Page 12: ...stem while out of this position Transportation Configuration Label Assembly of the Sesamoid Plasty 1 Unfold the first pole section located close to the base of the Sesamoid Plasty Stand Tighten the locking mechanism of that pole section and complete the same operation for each pole section 2 Insert the camera arm into the hole situated on the upper pole section 3 Install the Sesamoid Plasty Camera...

Page 13: ...ards the floor holding the previously folded segments to prevent them from swinging unexpectedly CAUTION Remove the Sesamoid Plasty Camera and the Sesamoid Plasty Computer prior to undoing any of the locking mechanisms to fold the stand Failure to follow these instructions will result in an unexpected tilt of the Sesamoid Plasty Stand CAUTION The Sesamoid Plasty must never be submerged in water or...

Page 14: ...to the following points Pull connections apart by gripping the connector Do not pull them apart by tugging on the cable as this can damage the connecting cable and connector pins The system has a lanyard on the LEMO Sleeve which can be pulled directly to unmount the connector Do not leave cable connectors where they will get damaged particularly on the floor where they can easily be stepped on or ...

Page 15: ...rviceable parts Maintenance by untrained personnel may present an electric shock hazard The only user replaceable accessories are The laser pointer system s batteries The power HDMI and Ethernet cables CAUTION It is recommended to recalibrate the Sesamoid Plasty Camera once a year Contact Zimmer CAS Customer Support for more information CAUTION Contact Zimmer CAS Customer Support with any doubt re...

Page 16: ...9 kg including Sesamoid Plasty Computer Camera and Stand CLASSIFICATIONS Electric shock protection Class 1 protectively earthed with power from supply mains without applied parts Flammable atmosphere Not suitable for use in presence of a flammable anesthetic mixture with air oxygen or nitrous oxide POWER AC input requirements 100 240 V 1A max 50 60 Hz OPERATING CONDITIONS Humidity 10 90 Non conden...

Page 17: ...as those from portable and mobile devices may cause performance degradation CAUTION Portable radio frequency RF communications equipment including peripherals such as antenna cables and external antennas should be used no closer than 30 cm to the Sesamoid Plasty including cables Otherwise degradation of the performance of the equipment could result CAUTION Use of this equipment adjacent to other e...

Page 18: ... information Asynchronous information relative to current state of instruments Unintentional manipulations of the system CAUTION The emission characteristics of the Sesamoid Plasty make it suitable for use in industrial areas and hospitals CISPR 11 class A The Sesamoid Plasty is not adequate for use in a residential environment as it might not offer adequate protection to RF communication services...

Page 19: ...e instructions may cause harmful interference to radio communications However there is no guarantee that interference will not occur in a particular installation If this equipment does cause harmful interference to radio or television reception which can be determined by turning the equipment off and on the user is encouraged to try to correct the interference by one or more of the following measu...

Page 20: ...static discharge ESD IEC 61000 4 2 8 kV contact 2 4 8 15 kV air 8 kV contact 2 4 8 15 kV air Floors should be wood concrete or ceramic tile If floors are covered with synthetic material the relative humidity should be at least 30 Electrical fast transient burst IEC 61000 4 4 2 kV for power supply lines 1 kV for input output lines 2 kV line s to line s 1 kV line s to earth Mains power quality shoul...

Page 21: ...ers m Field strengths from fixed RF transmitters as determined by an electromagnetic site surveya should be less than the compliance level in each frequency rangeb Interference may occur in the vicinity of equipment marked with the following symbol Note At 80 MHz and 800 MHz the higher frequency range applies Note These guidelines may not apply in all situations Electromagnetic propagation is affe...

Page 22: ...s or returned to Zimmer Biomet for recycling See Symbols section page 2 for further information The batteries directive 2006 66 EC includes requirements on the removability of batteries from waste equipment in EU Member States To comply with this directive this device has been designed for the safe removal of the batteries at end of life by a waste treatment facility ...

Page 23: ...e stiffness loosen up the screw by turning it counter clockwise 3 Verify and adjust the stiffness of the camera arm until it holds its position Location of the set screw that adjusts the stiffness of the camera arm Communication Errors When the Sesamoid Plasty Camera communication error message is displayed 1 Verify that both LEDs are on and green 3 Verify that the cable is plugged firmly into the...

Page 24: ...t and www zimmerbiomet com Not for distribution in France Check for country product clearances and reference product specific instructions for use Polaris Spectra is a trademark of Nothern Digital Inc LEMO is a trademark of Interlemo Holding SA Manfrotto is a trademark of Lino Manfroto Co Spa Caution Federal U S law restricts this device to sale by or on the order of a physician 2016 Zimmer Biomet...

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