Lazurite ArthroFree, Инструкция по эксплуатации, Страница: 34 / 39

34 The ArthroFree System
Cleaning and
Sterilization
Always follow the care and cleaning instructions in this manual. Any deviation may
damage the device and/or create health hazards for the patient, clinician, or user.
To protect common routes of infectious entry, appropriate PPE should always be worn
when handling and processing Components of the ArthroFree System. Lazurite does not
make recommendations on individual PPE needs. To determine proper PPE, please refer
to the rules and regulations of your surgical facility and the Centers for Disease Control
and Prevention website at www.cdc.gov/hai .
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.
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. To avoid spread of any potential agents, always employ standard
universal precautions when handling the 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.
Any devices observed to be soiled 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 with a patient.
Disposal The Components of the ArthroFree System are not serviceable by the user. Do not open or
disassemble any part of the ArthroFree System. Doing so may cause leakage, damage to
electronics, sterilization failure, and/or electric shock.
Cautions
To avoid potentially damaging the Components of the ArthroFree System, please take note of the CAUTIONS
identified throughout this document as summarized below. The warranty is void if any caution is disregarded.
TABLE 6: Cautions
Section Caution
US federal law restricts this device to use by, or on the order of, a physician.
Product Description
and Intended Use
Do not pull on the light cable to remove the Camera Head and light source from
the Sterilization Tray.
System Setup The Receiver requires electricity via a hospital-grade electrical outlet. Position the
Receiver so that the plug is easily accessible.
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).
The Battery Charger requires electricity via a hospital-grade electrical outlet.
Position the Battery Charger so that the plug is easily accessible.
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).