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The ArthroFree System

Contact Information  ................................................................................. 2

Important Safety Notice  .......................................................................... 5

Defined Terms  ............................................................................................. 5

Symbol Definitions  .................................................................................... 6

Product Description and Intended Use  ............................................ 7

ArthroFree Wireless Camera Head 

 ................................................................ 8

ArthroFree Battery 

 ......................................................................................... 9

ArthroFree Battery Charger 

 ........................................................................  10

ArthroFree Receiver 

 ....................................................................................  11

ArthroFree Sterilization Tray 

 .......................................................................  11

System Compatibility  ............................................................................  13

System Setup  .............................................................................................  14

Operating Instructions  .........................................................................  18

Wireless Visualization ............................................................................  23

Cleaning and Sterilization  ...................................................................  24

Camera Head and Battery 

 .........................................................................  25

Battery Charger and Receiver 

 ....................................................................  26

Storage  .........................................................................................................  27

Service Life  .................................................................................................  28

Disposal  .......................................................................................................  29

Technical Specifications  .......................................................................  30

Federal Communications Commission ID  ...................................  32

Warnings, Cautions, and Notes  .........................................................  33

Troubleshooting  ......................................................................................  37

Table of Contents

Содержание ArthroFree

Страница 1: ...WARNING Before installing and using the ArthroFree System read this manual thoroughly especially the Warnings Cautions and Notes Instructions for Use Cleaning and Sterilization...

Страница 2: ...The ArthroFree System Contact Information For technical assistance or sales support contact Lazurite at 1 833 214 2324 Lazurite 4760 Richmond Road Suite 400 Cleveland OH 44128 United States of Americ...

Страница 3: ...Charger 10 ArthroFree Receiver 11 ArthroFree Sterilization Tray 11 System Compatibility 13 System Setup 14 Operating Instructions 18 Wireless Visualization 23 Cleaning and Sterilization 24 Camera Head...

Страница 4: ...oubleshooting Troubleshooting 37 38 FIGURES Section Page Figure 1 ArthroFree Camera Head ArthroFree Battery Pack Product Description and Intended Use 8 Figure 2 Control Buttons Product Description and...

Страница 5: ...arnings may result in injury to the patient clinician or user CAUTION indicates risks to the equipment Failure to follow Cautions may result in product damage NOTE indicates special information to cla...

Страница 6: ...Indicates the manufacturer s serial number for this specific device Fragile Handle with care Indicates a medical device that can be broken or damaged if not handled carefully Temperature limit Indicat...

Страница 7: ...ations The ArthroFree System is indicated for use in arthroscopy general laparoscopy nasopharyngoscopy ear endoscopy sinuscopy plastic surgery or wherever a laparoscope endoscope or arthroscope is ind...

Страница 8: ...0001 101 10 ArthroFree Receiver AF0002 101 10 ArthroFree Battery AF0003 101 10 ArthroFree Battery Charger AF0004 101 10 ArthroFree Sterilization Tray AF0005 101 10 ArthroFree Wireless Camera Head The...

Страница 9: ...existing C mount coupler and a scope The control buttons manage brightness digital zoom and white balance They enable still image and video capture when connected to a compatible pre existing capture...

Страница 10: ...inserting it completely into one of the five charging bays on the Battery Charger While a Battery charges the corresponding OLED display indicates its charging progress and the number of charging cyc...

Страница 11: ...or initiation of still photo and video capture on an existing data console Sterilization Tray When shipped as a kit or a set the Camera Head and three Batteries are packed in the Sterilization Tray Th...

Страница 12: ...12 The ArthroFree System FIGURE 6 ArthroFree Sterilization Tray Light Cable Light Source Batteries 3 Wireless Camera Head Lid...

Страница 13: ...patibility of the ArthroFree System with surgical tower components must be validated in clinical practice prior to first use To validate display a test image on the surgical display see Operating Inst...

Страница 14: ...main surgical display or the surgical tower 1 EITHER place the Receiver on top of the pre existing surgical display as shown in Figure 7 by a First connecting the provided VESA mount bracket to the ba...

Страница 15: ...ArthroFree Receiver 100mm VESA Mounting Width 200mm VESA Mounting Width Receiver Receiver Receiver Locking Screw Receiver Mounting Bracket VESA Mounting Bracket Receiver Receiver Mounting Bracket VESA...

Страница 16: ...port on the pre existing patient data console After installation test for picture triggering and adjust port selection as necessary WARNING Do not position the Receiver within the sterile field CAUTI...

Страница 17: ...ectrical outlet Position the Battery Charger so that the plug is easily accessible CAUTION When setting up the Battery Charger use only supplied cables and accessories Any other cables or accessories...

Страница 18: ...all Components for signs of damage or wear Any signs of damage including cracking hazing chips nicks scratches and abrasion on the Camera Head or battery housing should be reported and immediately ass...

Страница 19: ...light post of a pre existing endoscope Only pull from the main body of the light source Battery Insertion Removal and Replacement 1 To insert the Battery place it completely into the battery bay of th...

Страница 20: ...NG The Battery can be stored in the Battery Charger for as long as required 1 To insert a Battery line up the Battery with an open charging bay and gently insert the Battery fully until the Battery st...

Страница 21: ...record video of the wirelessly transmitted signal A short press of the camera button will activate remote trigger port 1 on the Receiver typically causing the capture of a still image of the displayed...

Страница 22: ...tery charge 0 segments Indicates Battery is below 1 3 of the maximum charge level Replace with a fully charged Battery The icon flashes when the Battery reaches a critically low charge level Wireless...

Страница 23: ...tical for successful use of the ArthroFree System NOTE The ArthroFree System is designed to provide a live video within ten feet of the Receiver with a clear line of sight between the Receiver and Cam...

Страница 24: ...Do not place any Component of the ArthroFree System in a moist heat sterilizer autoclave or automated washing device Temperatures in these units may cause damage to sensitive electronics or the lithiu...

Страница 25: ...at any point in their life or use cycle must be considered to be nonsterile and a potential source for disease transmission Any visibly soiled articles should be recleaned and sterilized prior to use...

Страница 26: ...es into the Sterilization Tray in the locations visually indicated by the image in the base of the Sterilization Tray 3 Wrap the Sterilization Tray in a double layer of sterilization wrap 3 4 Use a pr...

Страница 27: ...Batteries stored longer than 30 days should be recharged and reprocessed prior to use Repeated cleaning and sterilization may impact the expected service life of ArthroFree Components Inspect all Comp...

Страница 28: ...umber of times a Component in the ArthroFree System is used cleaned or sterilized Actual service life is determined by factors such as handling wear sterilization methods chemical exposure and time be...

Страница 29: ...dance with all applicable state and local regulations The Camera Head Receiver and Battery Charger contain electronic equipment Such Components must not be disposed of as unsorted municipal waste and...

Страница 30: ...4 1V max charging voltage 100 240 VAC 50 60 Hz XX A Not applicable Device weight 371g 294g 83g 800g 1400g Classification Class II equipment Class II equipment Class II equipment Unclassed Class II eq...

Страница 31: ...y is restricted to repair or replacement by Lazurite at its option of any product found to be defective during the warranty period Damage inflicted on a product by the user will result in additional c...

Страница 32: ...s FCC ID 2AZYQ 01A This device complies with Part 15 of FCC Rules Operation is subject to the following two conditions 1 this device may not cause harmful interference and 2 this device must accept an...

Страница 33: ...Battery with the Battery Charger provided in the ArthroFree System Failure to follow these instructions may result in damage to the Battery damage to the Battery Charger a fire or explosion and or in...

Страница 34: ...y point in their life or use cycle must be considered to be nonsterile and a potential source for disease transmission Any visibly soiled articles should be recleaned and sterilized prior to use with...

Страница 35: ...e any ArthroFree Component in liquid Doing so may irreparably damage the Component Disconnect the Battery Charger and Receiver from the AC power source before cleaning Never clean the charging contact...

Страница 36: ...ource is designed to connect to an ACMI snap in groove on the light post Any pre installed light post adapters corresponding to other attachment standards should be removed prior to connecting the lig...

Страница 37: ...ersists contact Lazurite technical support Picture is too dark Increase brightness by quickly pressing and releasing the multifunction button on the Camera Head until the brightness icon is displayed...

Страница 38: ...onnect before restarting surgery Battery fails to charge or is not detected Place Battery into different charger bay Replace Battery The Receiver indicator light is off Check that power is being deliv...

Страница 39: ...hnologies See www lazurite co patents for more details Lazurite 4760 Richmond Road Suite 400 Cleveland OH 44128 United States of America 1 833 214 2324 1900D 20221 0 2022 Copyright Lazurite Lazurite A...

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