Dentsply Sirona Purevac HVE Manual

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Purevac® HVE System
HVE Mirror Tips and Hose Adapter Starter Kit
Directions for Use
Please read carefully and completely before operating unit.

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Overview 3
Intended Use 3
Contraindications 3
Warnings 3-4
Precautions 4
Adverse Reactions 4
Device Description 5
Unpacking the System 5
Preparation for Use 6-8
Infection Control Procedures 9-12
Specifications 13
Disposal of Unit 13
TABLE OF CONTENTS

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OVERVIEW
The Dentsply Sirona HVE Mirror Tip and Hose Adapter Starter Kit offers a new and unique dental solution for high volume
evacuation (HVE). The kit includes three (3) HVE Mirror Tips with an ergonomic unibody design and built-in mirror that allows
for evacuation, illumination, retraction, and visualization with one hand. The HVE Hose Adapter allows the HVE Mirror Tip to be
used in the most effective and comfortable manner, with a lightweight, flexible, and durable hose that provides greatly improved
ergonomic support. The HVE Hose Adapter connects directly to a standard 11 mm HVE valve and also includes a 360° swivel
connection for the HVE Mirror Tip and a holster to secure the system when not in use.
INTENDED USE
The Dentsply Sirona HVE Mirror Tip and Hose Adapter Starter Kit is intended to provide oral high volume evacuation, visualization,
illumination, and retraction during dental procedures. The device is intended to be used by trained dental professionals only.
CONTRAINDICATIONS
There are no known contraindications.
WARNINGS
• Only use compatible HVE tips with the Dentsply Sirona HVE Hose Adapter.
• Sterilizing the HVE Hose Adapter will cause component damage. Disinfect the HVE Hose Adapter using only the tested and
approved disinfectants listed in the Infection Control Procedures Section.
• The HVE Mirror Tips must be steam sterilized before first use and between patients to prevent patient cross-contamination. See
Infection Control Procedures Section.
• The HVE Mirror Tip is designed to last up to 100 reprocessing cycles and the HVE Hose Adapter is designed to last up to 2,500
reprocessing cycles. Use of the device beyond its useful life may cause damage to equipment and increases risk of patient cross-
contamination.

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• 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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DEVICE DESCRIPTION
HVE Mirror Tip HVE Hose Adapter
Hose Snap
Connection
HVE Mirror Tip 360˚
Swivel Connection
Holster
HVE Valve
Connection
HVE Opening
Continuous Flow
Inlet Ports
Mirror
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.

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Method Figure
Remove the HVE Hose Adapter (Figure 1) and three pack of HVE Mirror Tips
from packaging.
Figure 1
Locate the existing HVE valve (Figure 2) on your dental chair.
Figure 2
HVE Valve
Low Speed Valve
PREPARATION FOR USE

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Method Figure
Take the HVE Hose Adapter and position for insertion into the HVE valve (Figure 3).
Fully and securely insert the HVE Hose Adapter into the HVE valve (Figure 4).
Ensure the HVE Hose Adapter sits securely in the existing HVE valve (Figure 5).
Figure 3
Figure 4
Figure 5

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Method Figure
Take one HVE Mirror Tip (Figure 6) and insert directly into the HVE Hose
Adapter (Figure 7).
Ensure the HVE Mirror Tip is secure in the HVE Hose Adapter.
*Before patient use, HVE Mirror Tips must be cleaned and sterilized.
Go to “Infection Control Procedures” for reprocessing instructions. Figure 6 Figure 7
Ensure the operatory suction system is on. Refer to the manufacturer’s
instructions for use.
On the chair’s HVE valve, switch the lever from off to on.
Once on, suction should be flowing through the HVE Mirror Tip and ready
for use.

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INSTRUCTIONS FOR REPROCESSING THE HVE MIRROR TIP
Reprocessing Step Method Warning
Point of Use • Turn suction off by switching the lever from on to off on existing
HVE valve.
• Remove the HVE Mirror Tip from the HVE Hose Adapter.
• It is recommended that instruments are reprocessed as soon as is
reasonably practical following use.
• Do not attempt to remove
the HVE Mirror Tip from the
HVE Hose Adapter while the
HVE system is operating.
Cleaning • Remove gross soil by rinsing under water of at least drinking quality.
• Prepare enzymatic instrument cleaning solution per the
manufacturer’s recommendation in a soaking container or
ultrasonic bath.
• Place the HVE Mirror Tip in the solution for the time specified by the
solution manufacturer for cleaning.
• Rinse the HVE Mirror Tip under running water of at least drinking
quality for a minimum of 30 seconds to remove detergent residue.
• Allow the HVE Mirror Tip to dry.
• Visually inspect the HVE Mirror Tip for visible soil. If visible soil is
present, repeat the cleaning procedure.
• Do not use hard wire brushes
to clean the HVE Mirror Tip
as scratching can occur.
Dentsply Sirona recommends
the use of Resurge®
Instrument Cleaning Solution.
INFECTION CONTROL PROCEDURES

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INSTRUCTIONS FOR REPROCESSING THE HVE MIRROR TIP
Reprocessing Step Method Warning
Sterilization • Place each HVE Mirror Tip in a separate steam-sterilization pouch.
• Place bagged HVE Mirror Tip into a steam sterilizer, per the sterilizer
manufacturer’s instructions.
• The following minimum sterilization cycles may be used:
• Gravity steam sterilization – full cycle: 135 °C for 10 minutes.
• Pre-vacuum steam sterilization – full cycle: 121 °C for 15 minutes.
• Pre-vacuum steam sterilization – full cycle: 135 °C for 3 minutes.
• Steam flush/pressure pulse sterilization (e.g. STATIM) – full cycle:
134 °C for 3.5 minutes.
• Alternate method: place non-bagged instruments into the steam
sterilizer and run at the above listed cycles.
Before patient use, HVE
Mirror Tips must be cleaned
and sterilized.
Dentsply Sirona recommends
the use of Assure Plus®Self-
Sealing Sterilization Pouches.
Note: Instruments sterilized
non-bagged should be used
immediately.

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INSTRUCTIONS FOR REPROCESSING THE HVE HOSE ADAPTER
Reprocessing Step Method Warning
Point of Use • Turn suction off by switching the lever from on to off on existing HVE
valve.
• Remove the HVE Mirror Tip from the HVE Hose Adapter.
• Do not attempt to remove
the HVE Mirror Tip from the
HVE Hose Adapter while the
HVE system is operating.
Cleaning &
Disinfection: Manual
• To remove visible soil, thoroughly wipe the entire outer surface of the
HVE Hose Adapter, including the entire length of the hose and the
holster, with a new, single-use wipe in combination with an
alcohol-based, tuberculocidal, cleaning and disinfecting solution.
Use additional wipes as needed to ensure all visible soil is removed.
• Pay special attention to all seams and crevices while wiping.
• If soil is observed in the seam area of the HVE Hose Adapter,
disassemble the unit by unscrewing the top plastic component
(Figure 8), carefully removing the metal ring (Figure 9) and wiping
the components separately (Figures 10 and 11). Once visually clean,
place the metal ring back into the top plastic component and screw
the plastic pieces back together.
• Use only a disinfecting
solution which is approved
for its efficacy, EPA
registered (and/or Health
Canada approved), and use
in accordance with the DFU
of the disinfecting solution
manufacturer.
Dentsply Sirona recommends
the use of VoloWipes®
Disinfecting/Deodorizing/
Cleaning Wipes.
Figure 8 Figure 9 Figure 10 Figure 11

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INSTRUCTIONS FOR REPROCESSING THE HVE HOSE ADAPTER
Reprocessing Step Method Warning
Cleaning &
Disinfection: Manual
(continued)
• To disinfect the device, use additional wipes as needed to ensure the
entire outer surface, including seams and crevices, remain visibly wet
for the contact time recommended by the solution manufacturer.
• Allow the device to air dry.
*VoloWipes®Disinfecting
Wipes have a two minute
contact time.
Cleaning: Internal • At the end of each day, clean the inside of the HVE Hose Adapter
with evacuation cleaner following the manufacturer’s directions
for use.
• The HVE Hose Adapter must
be cleaned with evacuation
cleaner at the end of each
day to maintain its optimal
function.
Dentsply Sirona recommends
the use of Purevac® SC
Evacuation Cleaner.

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SPECIFICATIONS
Weight HVE Mirror Tip: 15.5 g or 0.55 oz.
HVE Hose Adapter: < 109.7 g or < 3.87 oz.
Dimensions HVE Hose Adapter Length: 1.524 m or 60 in.
HVE Hose Adapter Swivel Connection I.D.: 15.875 mm or 0.625 in.
HVE Hose Adapter Valve Connection O.D.: 11.252 mm or 0.443 in.
HVE Mirror Tip Length: 128.53 mm or 5.06 in.
HVE Mirror Tip Valve Connection O.D.: 15.215 mm or 0.599 in.
HVE Mirror Tip Mirror Diameter: 17.85 mm or 0.703 in.
HVE Mirror Tip Bore Opening Area: 90.406 mm2 or 0.140 in2
Operating Environment Ambient Temperature: -35 °C to 70 °C or -31 °F to 158 °F
Relative Humidity Range: 10% to 95% non-condensing
Atmospheric Pressure: 50 kPa to 106 kPa or 0.49 atm to 1.05 atm
Transport and Storage
Conditions
Ambient Temperature: 10 °C to 40 °C or 50 °F to 104 °F
Relative Humidity Range: 30% to 75% non-condensing
Atmospheric Pressure: 70 kPa to 106 kPa or 0.69 atm to 1.05 atm
DISPOSAL OF UNIT
Dispose of the system components in accordance with federal, state, and local laws.

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11081 Rev. 1 (0618)
Manufactured by:
Dentsply Sirona
1301 Smile Way
York, PA 17404 USA
DENTSPLY DeTrey GmbH
De-Trey Strasse 1
78467 Konstanz
Germany
dentsply.eu/ifu
dentsplysirona.com
See webpage for
instructions for use