Lazurite ArthroFree User manual

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

2The 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 America

3The ArthroFree System
Contact Information ................................................................................. 2
Important Safety Notice .......................................................................... 5
Dened Terms ............................................................................................. 5
Symbol Denitions .................................................................................... 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 Specications ....................................................................... 30
Federal Communications Commission ID ................................... 32
Warnings, Cautions, and Notes ......................................................... 33
Troubleshooting ...................................................................................... 37
Table of Contents

4The ArthroFree System
TABLES
Section Page
Table 1: Symbols Associated with ArthroFree Wireless
Surgical Camera System Symbol Definitions 6
Table 2: ArthroFree Wireless Surgical Camera System
Components Product Description and Intended Use 8
Table 3: Icons That Appear on the Surgical Display
While the ArthroFree System is in Use Operating Instructions 22
Table 4: Technical Specifications Technical Specifications 30
Table 5: Warnings Warnings, Cautions, and Notes 33-34
Table 6: Cautions Warnings, Cautions, and Notes 34-35
Table 7: Notes Warnings, Cautions, and Notes 36
Table 8: Troubleshooting 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 Intended Use 9
Figure 3: ArthroFree Battery Product Description and Intended Use 10
Figure 4: ArthroFree Battery Charger Product Description and Intended Use 10
Figure 5: ArthroFree Receiver Product Description and Intended Use 11
Figure 6: ArthroFree Sterilization Tray Product Description and Intended Use 12
Figure 7: Mounting the ArthroFree Receiver System Setup 15
Figure 8: ArthroFree Receiver Connections System Setup 16
Figure 9: ArthroFree Camera with Light Engine Above
the Light Post Operating Instructions 19
Figure 10: Recommended Environmental Conditions Storage 27

5The ArthroFree System
Important Safety Notice
Before operating this device, please read this manual thoroughly. When using this device, the wireless
transmission may fail if the instructions in this manual are not followed. Keep additional packaged Batteries
charged and subsequently sterilized so a backup Battery is available when needed.
“WARNING” indicates risks to the safety of the patient, clinician, or user. Failure to follow Warnings 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 clarify instructions or present additional information.
Warnings, Cautions, and Notes appear in many of the sections below.
To see the comprehensive list of Warnings, Cautions, and Notes in this manual, see the section Warnings,
Cautions, and Notes.
Dened Terms
Capitalized terms in this document are defined either (1) in the text as oset by parentheses and quotation
marks, or (2) as labeled items called out in the figures included herein.

6The ArthroFree System
Symbol Denitions
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.
TABLE 1: Symbols Associated with the ArthroFree Wireless Surgical Camera System
Symbol Meaning Definition
Caution Indicates the need for the user to consult these instructions for important
information such as warnings and cautions.
Risk of electric shock Warns of electricity.
Manufacturer Indicates the medical device manufacturer.
Date of
manufacture Symbol for date of manufacture; accompanied by a date.
Batch code Indicates the manufacturer’s batch code, lot number, or batch number for
this device. Note: synonyms include “lot number” and “batch number.”
Catalog number
Indicates the manufacturer’s catalog, reference, or reorder number for this
specific device. Note: synonyms include “reference number” and “reorder
number.”
Serial number 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 Indicates the temperature limits to which the medical device can be safely
exposed.
Storage humidity
range
Indicates the humidity limits to which the medical device can be safely
exposed.
Atmospheric
pressure
Indicates the pressure limits to which the medical device can be safely
exposed.
Type BF symbol Identifies a type BF applied part complying with IEC 60601-1.
Do not immerse in
any liquid Indicates that the appliance must not be immersed in liquid.
Refer to IFU Indicates that critical information can be found in this manual, the
Instructions for Use (IFU).
R
X
Rx only Indicates that the product is a medical device; US federal law restricts this
device to sale to—or on the order of—a physician.
FCC marking
Indicates that an electronic device sold in the United States is certified by,
and that electromagnetic interference from the device is under the limits
approved by, the US Federal Communications Commission (“FCC”).
Crossed-out
trash can
Indicates that a product should not be disposed of in a landfill; the black
bar indicates that the equipment was manufactured after 2005.

7The ArthroFree System
Product Description and Intended Use
The ArthroFree Wireless Surgical Camera System (“ArthroFree System”) is intended for use in endoscopic
surgical procedures to transmit live video from a surgical site to a pre-existing patient data console or
surgical display. 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. It is not intended to contact a patient or deliver any materials to a patient body.
The ArthroFree System was designed to eliminate the hassle and risks associated with fiber-optic and power
cables found in traditional endoscopic camera systems. It is designed to be drop-in compatible with most
currently marketed patient data consoles and surgical displays, and with most endoscopes directly or by use
of a pre-existing C-mount coupler.
CAUTION: Federal law in the United States of America (“US federal law”) restricts this device to use by, or on
the order of, a physician.
Indications
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 indicated for
use. The users of the camera include general surgeons, gynecologists, cardiac surgeons, thoracic surgeons,
plastic surgeons, orthopedic surgeons, ENT surgeons, neurosurgeons, and urologists.
The ArthroFree System is indicated for use in diagnostic and operative endoscopic procedures, supplying
illumination and visualization of an interior cavity of the body.
Examples of common general endoscopic surgeries are listed below.
• Laparoscopic cholecystectomy
• Laparoscopic hernia repair
• Laparoscopic appendectomy
• Laparoscopic pelvic lymph node dissection
• Laparoscopically assisted hysterectomy
• Laparoscopic and thoracoscopic anterior spinal fusion
• Anterior cruciate ligament reconstruction
• Knee arthroscopy
• Shoulder arthroscopy
• Small joint arthroscopy
• Decompression fixation
• Wedge resection
• Lung biopsy
• Pleural biopsy
• Dorsal sympathectomy
• Pleurodesis
• Internal mammary artery dissection for coronary artery bypass
• Coronary artery bypass grafting where endoscopic visualization is indicated
• Examination of the evacuated cardiac chamber during the performance of valve replacement

8The ArthroFree System
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.
e ArthroFree Wireless Surgical Camera System
The components of the ArthroFree System (“Components”) are listed below.
TABLE 2: ArthroFree Wireless Surgical Camera System Components
Component Product No.
ArthroFree Wireless Camera Head AF0001-101-10
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 Camera Head wirelessly transmits (1) live video, and (2) the status of the on-screen indicators to the
Receiver. The Camera Head includes: control buttons, a light source connected by the light cable to the main
body of the Camera Head, C-mount connector, battery bay, and Battery (when in use).
FIGURE 1: Side and top view of the ArthroFree Camera Head, with ArthroFree Battery
Light Source
C-mount
Connector
Light Cable
Control Buttons
Battery
Light Source Main Body of
Camera Head
C-mount
Connector

9The ArthroFree System
•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.
WARNING: The light source contains a Class 1 laser product. The
light source is designed to prevent danger from the laser enclosed
within it. Do not disassemble the light source. Use of the enclosed
laser without the protective design is potentially hazardous.
Do not look directly into the light source while disconnected or
through a scope.
•The C-mount connector allows for the mounting of a pre-existing C-mount endoscope or a
pre-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 system.
•The main body of the Camera Head is grasped during use.
ArthroFree Battery
The Battery provides power to the Camera Head. It features a completely sealed case fit for vaporized
hydrogen peroxide sterilization, which is not modifiable by the user. The Battery fits into the battery bay on
the Camera Head.
FIGURE 2: Control Buttons
Short press: zoom/brightness
Long press: white balance
Up/down arrows Camera icon (capture
picture and video)
WARNING: Do not short-circuit Batteries by bridging terminals with conductive materials, or open,
crush, or incinerate Batteries. Doing so may lead to shock, burn, damage to Battery, or user injury.
Failure to follow these instructions will void the warranty.

10The ArthroFree System
FIGURE 3: ArthroFree Battery
ArthroFree Battery Charger
The Battery Charger can simultaneously recharge up to five Batteries. Each of the five battery bays include a
display of battery charge status (see Operating Instructions).
WARNING: Only charge the Battery with the Battery Charger. Failure to follow these instructions
may result in damage to the Battery; damage to the Battery Charger; a fire or explosion; and/or
injury to the patient, surgeon, or user. Failure to follow these instructions will void the warranty.
Charge the Battery by 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 cycles completed. When a Battery is fully charged, the OLED display indicates “DONE CHARGING.”
Batteries may be stored in the Charger.
•To remove a Battery, pull it straight out of the charging bay, applying a small amount of force.
•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.
Battery Contacts
FIGURE 4: ArthroFree Battery Charger
OLED Display (5)
Charging Bay (5)
Battery End Cap

11The ArthroFree System
ArthroFree Receiver
The Receiver enables wireless transmission of the video signal from the Camera Head to a pre-existing
surgical display and patient data console equipped to display and store images and video. When a Battery
is inserted to power on the Camera Head, the Receiver automatically pairs with the Camera Head, initiating
wireless video transmission (see Operating Instructions).
The Receiver utilizes two DVI-out ports, an AC power port, and two remote trigger ports for 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.
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.
CAUTION: Do not pull on the light cable to remove the Camera Head and light source from the Sterilization
Tray.
Remote Trigger Port #1: Long Press Remote Trigger Port #2: Short Press
FIGURE 5: ArthroFree Receiver
DVI-out (2)
AC Power
Indicator Light
Green: Power On
Blue: Camera Connected

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

13The ArthroFree System
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).
Should you experience problems, contact Lazurite technical support (see Contact Information).

14The ArthroFree System
System Setup
Installation and Connection
WARNING: Carefully unpack all ArthroFree Components and verify that no damage occurred during shipment.
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.
WARNING: The ArthroFree System is not shipped sterile. The Camera Head and Batteries must be properly
sterilized prior to use in surgery (see Cleaning and Sterilization).
NOTE: For assistance with installation and setup of the ArthroFree System, please contact Lazurite technical
support.
Receiver Installation
Determine the best location in the operating room for the Receiver. For optimal signal strength and image
quality, choose a location that allows for a direct line of sight from Receiver to operating table (e.g., on top of
the 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 back of the surgical display using
appropriate screws for the pre-existing surgical display. Refer to Figure 7 for adjusting to the size
of the pre-existing surgical display.
b. Then, slide the provided Receiver mounting bracket flush onto the VESA mounting bracket. Using
the provided screws and nuts, set the receiver mounting bracket so that it is flush with the front
of the surgical display and then use a 2.5mm hex key to tighten and lock into place. Do not
overtighten.
c. Lastly, slide the Receiver onto the receiver mounting bracket and using the provided receiver
locking screw and a 2.5mm hex key, secure the receiver in place. Do not overtighten.
OR place the Receiver in a secure and stable location and ensure that there are no obstructions
between it and the operating table.
NOTE: The included receiver mounting bracket is compatible with a 100mm or 200mm VESA mounting
pattern on a pre-existing surgical display. Contact Lazurite for additional technical support.
NOTE: The Receiver should be placed within ten feet of the location where the Camera Head will be
used.

15The ArthroFree System
FIGURE 7: Mounting the 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 Mounting Bracket
Pre-existing Surgical Display

16The ArthroFree System
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.
If the Receiver is placed further than ten feet away from the pre-existing patient data console, use a
longer DVI cable.
3. Connect the provided power cable to the AC power port on the back of the Receiver and plug in male
end of power cord to a hospital-grade electrical outlet.
4. Connect the video trigger cable to remote trigger port #1 on the back of the Receiver and to the video
remote trigger port on the pre-existing patient data console. After installation, test for video triggering
and adjust port selection as necessary.
5. Connect the picture trigger cable to remote trigger port #2 on the back of the Receiver and to the
picture remote trigger 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.
CAUTION: The Receiver requires electricity via a hospital-grade electrical outlet. Position the
Receiver so that the plug is easily accessible.
CAUTION: When setting up the Receiver, use only supplied cables and accessories. Any other
cables or accessories may result in increased EMC emissions (See Technical Specifications:
Electromagnetic Compatibility).
Battery Charger Installation
1. Place the Battery Charger on a flat, secure, and stable surface in a well-ventilated and secure location.
2. Ensure that there are no foreign substances in the charger bays.
3. Connect the AC power cord to a hospital-grade outlet. Ensure that this outlet is not being used for life-
support equipment.
4. Each charger bay should now indicate "NO BATTERY" on its respective OLED display.
FIGURE 8: ArthroFree Receiver Connections
DVI-out (2)
AC Power
Remote Trigger Port #1: Long Press
Remote Trigger Port #2: Short Press

17The ArthroFree System
CAUTION: The Battery Charger requires electricity via a hospital-grade electrical 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 may result in increased EMC emissions (See Technical Specifications:
Electromagnetic Compatibility).

18The ArthroFree System
Operating Instructions
WARNING: Before using the ArthroFree System in a surgical procedure, test all Components to
ensure proper function. To test the Camera Head, power it on by inserting a Battery and then
point it at an object. Ensure that a live video of that object appears on all connected surgical
displays in the proper orientation.
WARNING: The ArthroFree user must be a qualified healthcare provider and must be familiar with
the instructions for use of the equipment and any applicable surgical techniques.
CAUTION: Do not drop any Component of the ArthroFree System, including the Camera Head and
Batteries. The Camera Head contains sensitive Components that are precisely aligned. Damage
to the device may impair functionality, prevent proper sterilization, or both. The battery contains
lithium-ion cells that, if damaged, may result in a runway reaction, causing smoke and fire.
NOTE: Before each use of the ArthroFree System, ensure that all Components are set up according to
instructions in the System Setup section of this manual. Before each use, and after each Battery change, verify
that the surgical display provides a live video with the correct image orientation.
Inspection of the Camera Head
Before each use, fully inspect 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 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.
Endoscope Attachment
Attach a pre-existing C-mount endoscope or pre-existing C-mount coupler to the Camera Head.
EITHER
1. Screw a pre-existing C-mount endoscope clockwise onto the Camera Head until it forms a tight seal.
Do not overtighten.
OR
2. Attach a pre-existing C-mount coupler to the Camera Head and then attach a compatible pre-
existing endoscope.
i. Screw the C-mount coupler clockwise onto the Camera Head until it forms a tight seal. Do not
overtighten.
ii. Open the endoscope clamp and insert the compatible endoscope into the scope end of the
coupler.
iii. Release the endoscope clamp.
NOTE: Always verify proper connection between the Camera Head and any applicable couplers and scopes.
Failure to do so may result in loss of the surgical image, damage to the Camera Head, or fluid accumulation
that may obscure the image transmitted from the Camera Head to the surgical display. For C-mount scopes
(i.e., those requiring no coupler), thread the endoscope directly onto the Camera Head until it forms a tight
seal. Do not overtighten.

19The ArthroFree System
Connecting and Disconnecting the Light Source
Gently press the light source onto the ACMI snap-in groove on the light post of the pre-existing endoscope
until it clicks in.
To remove the light source, pull on the main body of the light source with a small amount of pressure to
disconnect it from the light post of the pre-existing endoscope.
NOTE: No rotation is necessary when attaching the light source. The light source will rotate freely even after it
is secured onto the light post.
NOTE: The light source 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
light source to a pre-existing endoscope.
CAUTION: Do not pull on the light cable to disconnect the light source from the 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 the Camera Head, aligning it as
indicated by the shape of the exterior housing of the main body of the Camera Head.
2. Once the Battery is inserted, the Camera Head will automatically connect to the nearest unpaired and
powered on Receiver.
3. With the Battery inserted, visually confirm signal strength on the pre-existing and connected surgical
display.
4. To ensure that the pre-existing endoscope is properly attached to the Camera Head, perform a motion
image check: move the scope to verify that the video on the surgical display continually corresponds
with the object the Camera Head is pointing at.
5. To remove the Battery, pull it straight out of the Camera Head, applying a small amount of force to the
battery end cap.
FIGURE 9: ArthroFree Camera with Light Engine Above the Light Post
Press down to connect; pull up
to remove. No rotation necessary.

20The ArthroFree System
NOTE: If the Battery is removed or becomes depleted during surgery, the Camera Head will turn o and
the connected surgical display will appear black and revert to the startup image. In this event, immediately
cease operation of any surgical instruments, and remove instruments and scope from the patient. Replace
the depleted Battery with a fully charged Battery and wait for the Camera Head to reconnect to the Receiver
before resuming the procedure. The Camera Head will automatically reconnect to the Receiver and a video
will appear to the connected surgical display when a fully charged Battery is inserted.
CAUTION: Ensure that the battery bay of the Camera Head is free of debris prior to inserting a Battery.
Charging the Battery
Charge the Battery by inserting it completely into one of the charger bays on the Battery Charger. While
a Battery is charging, the corresponding OLED display indicates its charging progress and the number of
charging cycles completed. Once the charging cycle is complete, the status display of the Battery Charger will
indicate “DONE CHARGING.” 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 stops.
2. Once inserted, the Battery will automatically begin charging and its corresponding OLED display will
indicate charging progress and the number of charge cycles completed.
3. To remove a Battery, pull it straight out of the Battery Charger by applying a small amount of force.
4. Up to five Batteries can be charged at the same time using the provided Battery Charger.
WARNING: Do not position the Battery Charger within the sterile field.
CAUTION: Ensure that the battery bay of the Battery Charger is free of debris prior to inserting a Battery.
Connecting to the Receiver
Ensure that the Receiver has been installed and is powered on. See Receiver Installation for instructions. The
powered-on Receiver will automatically and wirelessly connect to the Camera Head when the Camera Head
is powered on.
Powering On and O the Camera Head
1. To power on the Camera Head, insert a fully charged Battery into its battery bay.
2. To power o 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.