33
The ArthroFree System
Warnings, Cautions, and Notes
Please ensure that all staff and medical professionals using this equipment read and understand this manual
thoroughly. Failure to do so may result in incorrect operation and lead to patient harm.
Warnings, cautions, and notes are listed here in the order they appear above.
Warnings
To avoid potentially serious injury to the patient, clinician, or user. and to reduce the risk of damage to the
ArthroFree System, please take note of the WARNINGS identified throughout this document as summarized in
Table 4 below. The warranty is void if any warning is disregarded.
TABLE 5: Warnings
Section
Warning
General
Warnings
Before installing and using the ArthroFree System, read this manual thoroughly, especially
the Warnings, Cautions, and Notes.
Product
Description
and Intended
Use
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.
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.
Only charge the 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 injury to the patient, clinician, or user. Failure
to follow these instructions will void the warranty.
System Setup
Carefully unpack all ArthroFree Components and verify that no damage occurred during
shipment. 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.
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).
Do not position the Receiver within the sterile field.
Operating
Instructions
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 and ensure that a video image of that object appears on all
connected surgical displays.
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.
Do not position the Battery Charger within the sterile field.
Do not power on more than one ArthroFree Camera Head within range of a single Receiver.