Precautions; Adverse Reactions; Residual Risks; Device Description - Dentsply Sirona Purevac HVE System Instrucciones De Uso

• It is the responsibility of the Healthcare Professional to determine the appropriate uses of this product and to understand:
• the health of each patient
• the dental procedures being undertaken
• applicable industry and governmental agency recommendations for infection control in dental healthcare settings
• requirements and regulations for safe practice of dentistry
• these Directions for Use in their entirety
• Inspect the device before each use for worn, loose, or damaged parts. Do not attempt to use the device unless the HVE Mirror
Tip is properly installed. A loose HVE Mirror Tip could separate from the HVE Hose Adapter or HVE valve. Reinstall the HVE
Mirror Tip or replace any damaged parts as necessary.
• Never install the HVE Hose Adapter or HVE Mirror Tip while the HVE system is operating.
• Dispose of the HVE Mirror Tip and HVE Hose Adapter according to CDC Guidelines for Infectious Waste and Federal, State, and
Local regulations.

PRECAUTIONS

• Before using this product, carefully read and follow all instructions and save them for future reference. Observe all precautions
and warnings.
• The HVE Hose Adapter can only be used with compatible HVE tips (15 mm) and was designed for the HVE Mirror Tip.
• The HVE Mirror Tip can only be used with compatible HVE valves (11 mm) and the HVE Hose Adapter.
• As with all dental procedures, use universal precautions (i.e., wear face mask, eyewear, face shield, gloves, protective gown, etc.).
• Oil and/or dirt may damage the HVE Hose Adapter's 360° swivel functionality.
• Take precaution during use with other dental instruments to avoid damage to the mirror and plastic.

ADVERSE REACTIONS

There are no known adverse reactions.
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RESIDUAL RISKS

Use of the device beyond its useful life may cause damage and increase risk of patient cross-contamination.
Failure to follow the validated reprocessing instructions provided may result in exposing the patient to cytotoxic residuals and/or
cross-contamination.

DEVICE DESCRIPTION

HVE Mirror Tip HVE Hose Adapter
Mirror
HVE Opening
HVE Valve
Connection
Continuous Flow
Inlet Ports
HVE Hose
Adapter
Connection

UNPACKING THE SYSTEM

As you unpack your Dentsply Sirona HVE Mirror Tip and HVE Hose Adapter Starter Kit, verify that the following components are
included: (1) HVE Hose Adapter, (3) HVE Mirror Tips, (1) Directions for Use
*Before patient use, HVE Mirror Tips must be cleaned and sterilized. Go to "Infection Control Procedures" for reprocessing
instructions.
Hose Snap
Connection
HVE Mirror Tip 360˚
Swivel Connection
Holster
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