Summary of Contents for Lazurite ArthroFree
- Page 1 Instructions for Use, Cleaning, and Sterilization WARNING: Before installing and using the ArthroFree System, read this manual thoroughly, especially the Warnings, Cautions, and Notes.
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Page 2: Contact Information
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 America The ArthroFree System... -
Page 3: Table Of Contents
Contact Information ................. 2 Important Safety Notice ................5 Defined Terms ..................... 5 Symbol Definitions ..................6 Product Description and Intended Use ..........7 ..............8 ArthroFree Wireless Camera Head ..................9 ArthroFree Battery ................ 10 ArthroFree Battery Charger ..................11 ArthroFree Receiver ............... - Page 4 Product Description and Intended Use Figure 7: Mounting the ArthroFree Receiver System Setup Figure 8: ArthroFree Receiver Connections System Setup Figure 9: ArthroFree Camera with Light Engine Above Operating Instructions the Light Post Figure 10: Recommended Environmental Conditions Storage The ArthroFree System...
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Page 5: Important Safety Notice
To see the comprehensive list of Warnings, Cautions, and Notes in this manual, see the section Warnings, Cautions, and Notes. Defined Terms Capitalized terms in this document are defined either (1) in the text as offset by parentheses and quotation marks, or (2) as labeled items called out in the figures included herein. The ArthroFree System... -
Page 6: Symbol Definitions
In addition to the symbols already listed, other symbols found on the ArthroFree Wireless Surgical Camera System and in this manual have specific meanings directing proper use and storage of the ArthroFree Wireless Surgical Camera System. Table 1 below defines the symbols associated with this product. -
Page 7: Product Description And Intended Use
The ArthroFree System also enables the capture of still images and video from the live video stream when connected to a pre-existing patient data console. The ArthroFree System neither stores data nor performs diagnoses. -
Page 8: Arthrofree Wireless Camera Head
Contraindications Do not use the ArthroFree System if endoscopic surgery is contraindicated. Do not use the ArthroFree System if the environmental conditions for use do not meet the standards or regulations defined in this manual. The ArthroFree Wireless Surgical Camera System The components of the ArthroFree System (“Components”) are listed below. -
Page 9: Arthrofree Battery
• The light source is powered by Lazurite’s Meridiem™ light technology and is connected by the light cable to the main body of the Camera Head. The light source connects to the snap-in AMCI groove on the universal light post of an endoscope. -
Page 10: Arthrofree Battery Charger
Up to five Batteries can be charged at the same time in the Battery Charger. • Lazurite (“Lazurite”) recommends Battery replacement after 300 charge cycles. NOTE: Lazurite recommends using Batteries that have been charged within the last 30 days. The ArthroFree System... -
Page 11: Arthrofree Receiver
When shipped as a kit or a set, the Camera Head and three Batteries are packed in the Sterilization Tray. The Components, though, are not shipped sterile. When removing the Components of the ArthroFree System from the Sterilization Tray, proper removal is critical. First remove the light source, then the main body of the Camera Head. -
Page 12: Figure 6: Arthrofree Sterilization Tray
Light Cable Light Source Wireless Camera Head Batteries (3) FIGURE 6: ArthroFree Sterilization Tray The ArthroFree System... -
Page 13: System Compatibility
System Compatibility The ArthroFree System is standards compliant. The compatibility 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 Instructions). -
Page 14: System Setup
Verify that all parts are present and match items noted on the packing list. WARNING: If the packaging of the ArthroFree System (1) is damaged in any way prior to receipt by the customer, (2) has been opened prior to receipt by the customer, or (3) has been exposed to environmental conditions outside of those specified in Figure 9, contact Lazurite technical support before using. -
Page 15: Figure 7: Mounting The Arthrofree Receiver
100mm VESA 200mm VESA Mounting Width Mounting Width Receiver Receiver Receiver Mounting Bracket VESA Mounting Bracket Pre-existing Surgical Display Receiver Locking Screw Receiver Receiver Mounting Bracket VESA Mounting Bracket FIGURE 7: Mounting the ArthroFree Receiver The ArthroFree System... -
Page 16: Figure 8: Arthrofree Receiver Connections
Remote Trigger Port #2: Short Press Remote Trigger Port #1: Long Press FIGURE 8: ArthroFree Receiver Connections 2. Once the Receiver is in place, connect at least one of the provided DVI cables to one of the DVI-out connections on the back of the Receiver and to a DVI input on the pre-existing patient data console. - Page 17 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 may result in increased EMC emissions (See Technical Specifications: Electromagnetic Compatibility). The ArthroFree System...
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Page 18: Operating Instructions
Camera Head or battery housing—should be reported and immediately assessed to determine whether the ArthroFree System is suitable for use. The ArthroFree System is not designed to be field serviceable. If any Component is damaged or does not function properly, contact Lazurite technical support. -
Page 19: Figure 9: Arthrofree Camera With Light Engine Above The Light Post
Press down to connect; pull up to remove. No rotation necessary. FIGURE 9: ArthroFree Camera with Light Engine Above the Light Post Battery Insertion, Removal, and Replacement 1. To insert the Battery, place it completely into the battery bay of the Camera Head, aligning it as indicated by the shape of the exterior housing of the main body of the Camera Head. - Page 20 1. To power on the Camera Head, insert a fully charged Battery into its battery bay. 2. To power off the Camera Head, remove the Battery by pulling it straight out of the battery bay. WARNING: Do not power on more than one Camera Head within range of a single Receiver. The ArthroFree System...
- Page 21 4. Release the button. A second beep will sound, and the white balance icon will disappear. Using the Control Buttons The Camera Head features a four-control button keypad to control the functions of the ArthroFree System. The control buttons (see Figure 2) are labeled with a camera icon, three linear dots (multifunction button), and up and down arrows.
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Page 22: Table 3: Icons That Appear On The Surgical Display While The Arthrofree System Is In Use
Icons The following icons may be displayed on the connected and pre-existing surgical display when using the ArthroFree System: TABLE 3: Icons That Appear on the Surgical Display While the ArthroFree System is in Use Symbol Meaning Definition White balance Indicates Camera Head is adjusting the white balance. -
Page 23: Wireless Visualization
Setup section are critical 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 Camera Head. -
Page 24: Cleaning And Sterilization
Centers for Disease Control and Prevention website at www.cdc.gov/hai. WARNING: 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 lithium-ion cell and, in turn, put the patient, clinician, or user at risk of serious injury. -
Page 25: Camera Head And Battery
Reprocessing The ArthroFree System is not intended to come into contact with patients. However, the Camera Head and Batteries should be cleaned and sterilized between each use. Manual Cleaning Camera Head and Battery WARNING: Surgical procedures expose the Camera Head and Battery to patient tissue. Such tissue may contain viral agents (such as hepatitis and HIV), other pathogenic microorganisms, or etiologic agents. -
Page 26: Battery Charger And Receiver
Lazurite does not recommend placing any Components of the ArthroFree System into a moist heat (steam) sterilizer or an ethylene oxide sterilizer. These sterilization methods may cause irreparable damage to the ArthroFree System or result in severe bodily injury. Use of a sterilization method other than a low-temperature hydrogen peroxide plasma will void the warranty. -
Page 27: Storage
Following cleaning and sterilization, store the sterilized ArthroFree Components in the Sterilization Tray or sterilization wrap in which they were sterilized. Except as noted herein, the maximum shelf life for storage of ArthroFree Components shall be defined by facility-specific rules and regulations. -
Page 28: Service Life
Each Battery has an expected service life of 300 charge/discharge cycles. Expected service life is based on number 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 between uses. -
Page 29: Disposal
Disposal The Components of the ArthroFree System must be disposed of according to local laws and hospital practices. If no guidance is provided, please contact Lazurite for more information (see Contact Information). When disposing of Batteries, please reference local, state, and federal regulations regarding the safe disposal of lithium-ion batteries. -
Page 30: Technical Specifications
All medical electrical devices require special precautions to minimize risk to surrounding equipment. The ArthroFree System has been designed and tested to comply with IEC 60601-1-2 requirements for EMC with other devices. Do not use this equipment in the radio frequency shielded room of a medical electrical system for magnetic resonance imaging, where there are intense electromagnetic fields. - Page 31 For specific warranty information, contact Lazurite at 1.833.214.2324. This limited warranty 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 charges and may void the warranty.
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Page 32: Federal Communications Commission Id
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 any interference received, including interference that may cause undesired operation. The ArthroFree System... -
Page 33: Warnings, Cautions, And Notes
Verify that all parts are present and match those on the included packing list. If the packaging of the ArthroFree System (1) is damaged in any way prior to receipt by the customer, (2) has been opened prior to receipt by the customer, or (3) has been exposed to environmental conditions outside of those specified in Figure 9, contact Lazurite technical support before using. -
Page 34: Table 6: Cautions
Camera Head and Battery. Do not allow soil on devices to dry. Dried soil or tissue on the ArthroFree Camera Head or any of its subcomponents may make it more difficult to clean and/or sterilize the device. - Page 35 Operating Do not drop any Component of the ArthroFree System, including the Camera Head Instructions and Batteries. The Camera Head contains sensitive Components that are precisely aligned. Damage to the device may impair functionality and/or prevent proper sterilization The battery contains lithium-ion cells that, if damaged, may result in a runway reaction, causing smoke and fire.
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Page 36: Table 7: Notes
Wireless 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 Camera Head. While wireless icons seen on the pre-existing surgical display are indicators of wireless signal strength, there is no change in the performance of the ArthroFree System at any of the signal strength levels. -
Page 37: Troubleshooting
Confirm that the Receiver cables are securely connected and that connectors do not have broken pins or obstructions. • Remove and reinsert the Battery. • If the problem persists, contact Lazurite technical support. • Incorrect picture color Perform the white balance procedure (see White Balance). •... - Page 38 Check that power is being delivered to the Receiver. • Check that the power cable is connected to the power adapter. • Check for signs of damage to the power adapter or cable. If damaged, contact Lazurite technical support for replacement cables. The ArthroFree System...
- Page 39 Featuring our patented Meridiem™ and ArthroFree™ technologies. 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, ArthroFree, Meridiem, and are trademarks of Lazurite...
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