Vista Apex phasor User manual

408800
This manual must be read thoroughly and understood
prior to using the Phasor™ Composite Heating System.
Procedure Pack Assembled by:
Inter-Med, Inc.
2200 South St.
Racine, WI 53404 U.S.A.
Tel.: [phone]
Fax: [phone]
Toll Free: [phone]
www.vistaapex.com 408800-I-V-77-MUL (1)
Emergo Europe
Prinsessegracht 20
2514 AP The Hague
The Netherlands
Rx ONLY
Patent# 10,589,829
USER'S MANUAL
For use by qualied professionals only

TABLE OF CONTENTS
Introduction ....................................................................................... 3
Welcome to Vista Apex’s Phasor™ ..................................................................................... 3
Contents of the Phasor™ Kit ................................................................................................ 3
Intended Use / Indications for Use .................................................................................... 4
Phasor™ Set-Up and Use ................................................................... 4
Unpacking the Container ..................................................................................................... 4
Introduction .............................................................................................................................. 4
LED Indicators ........................................................................................................................... 5
Charging the Battery .............................................................................................................. 5
Phasor™ Operation ............................................................................ 6
Inserting Composite ............................................................................................................... 6
Composite & Setting Compatibility .................................................................................. 6
Selecting a Setting .................................................................................................................. 7
Start Heating Cycle ................................................................................................................. 7
Cleaning & Disinfection .......................................................................................................... 8
Infection Control Measures .................................................................................................. 9
Routine Maintenance .................................................................................................... 10-11
Battery Removal & Replacement ..................................................................................... 12
Troubleshooting Guide .................................................................. 12
Technical Data ................................................................................. 13
Symbol Identication ..................................................................... 14
Battery Disposal .............................................................................. 14
Safety Notes, Warnings and Precautions ................................. 15-16
Operating Conditions and Safety Consideration ......................... 17
Heat Generation ..................................................................................................................... 17
Cool-Down ............................................................................................................................... 17
Adverse Reactions ................................................................................................................. 17
Contraindications .................................................................................................................. 17
Vista Apex Terms and Conditions ofWarranty ............................. 18
Return Policy / Return Restocking Policy ...................................... 19
Appendix – Electromagnetic Compatibility ............................ 20-22
and Electrical Safety Information
2

TABLE OF CONTENTS
Introduction ....................................................................................... 3
Welcome to Vista Apex’s Phasor™ ..................................................................................... 3
Contents of the Phasor™ Kit ................................................................................................ 3
Intended Use / Indications for Use .................................................................................... 4
Phasor™ Set-Up and Use ................................................................... 4
Unpacking the Container ..................................................................................................... 4
Introduction .............................................................................................................................. 4
LED Indicators ........................................................................................................................... 5
Charging the Battery .............................................................................................................. 5
Phasor™ Operation ............................................................................ 6
Inserting Composite ............................................................................................................... 6
Composite & Setting Compatibility .................................................................................. 6
Selecting a Setting .................................................................................................................. 7
Start Heating Cycle ................................................................................................................. 7
Cleaning & Disinfection .......................................................................................................... 8
Infection Control Measures .................................................................................................. 9
Routine Maintenance .................................................................................................... 10-11
Battery Removal & Replacement ..................................................................................... 12
Troubleshooting Guide .................................................................. 12
Technical Data ................................................................................. 13
Symbol Identication ..................................................................... 14
Battery Disposal .............................................................................. 14
Safety Notes, Warnings and Precautions ................................. 15-16
Operating Conditions and Safety Consideration ......................... 17
Heat Generation ..................................................................................................................... 17
Cool-Down ............................................................................................................................... 17
Adverse Reactions ................................................................................................................. 17
Contraindications .................................................................................................................. 17
Vista Apex Terms and Conditions ofWarranty ............................. 18
Return Policy / Return Restocking Policy ...................................... 19
Appendix – Electromagnetic Compatibility ............................ 20-22
and Electrical Safety Information
2
IMPORTANT!
PLEASE NOTE! Prior to installation and start-up of the device,
please read these instructions carefully. As with all technical devices,
the proper function and safe operation of this device depend on the user’s
compliance with the standard safety procedures as well as the specic safety
recommendations presented in these Operating Instructions.
INTRODUCTION
Welcome to Vista Apex’s Phasor™
Congratulations on your decision to incorporate the Phasor™ heated
composite delivery system into your practice. This patent-pending device
is the rst of its kind, using NIR (near infrared) technology to rapidly warm
highly lled composite compules. With the touch of a button, Phasor™ is
able to heat composite material to 150°F in seconds, and maintain that
temperature throughout the procedure.
Warming composite signicantly lowers the viscosity of the material resulting
in better adaptation, reduced voids and microleakage, and improved depth
of cure. Materials remain highly sculptable, non-sticky, and easily shaped
during manipulation.
Our website, www.vistaapex.com, also provides information on new products,
accessories, and educational assistance for you and your professional sta.
If you have any questions regarding the use of the Phasor™, please call our
customer service department toll free at 877-418-4782.
Contents of the Phasor™ Kit
The Phasor™ is composed of the following:
(1) Handpiece
(3) Removable Nosecones
(100) Barrier Sleeves
(1) Stand
(1) Power Supply
(1) Device Maintenance Kit
(1) Instructions for Use
(1) Warranty Card
NOTE: ALL COMPONENTS
ARE NON-STERILE
Power Supply:
GlobTek, Inc.
186 Veterans Drive
Northvale, NJ 07647 U.S.A.
Tel.: [phone]
All Other Items:
Inter-Med, Inc.
2200 South St.
Racine, WI 53404 U.S.A.
Tel.: [phone]
3

Intended Use / Indications for Use
Heating and dispensing of dental composite materials.
PHASOR™ SET-UP AND USE
Unpacking the Container
No special assistance is required to unpack and assemble the Phasor™.
If you have questions or concerns, please visit www.vistaapex.com or call
Vista Apex at 877-418-4782 (Toll Free).
Packaging should be inspected upon arrival for evidence of shipping damage.
Damaged packaging may indicate the presence of an unsafe product and
the product should not be used until carefully inspected. If the package or
product is damaged, please contact Vista Apex at 877-418-4782 (Toll Free)
as well as the delivery service to le a complaint.
Introduction
Please reference the image below to familiarize yourself with the Phasor™.
DispensingTrigger
Battery Compartment
Programming /
Power Button
Charging Port
Removable
Nosecone
Snap-Fit Compule
Heating Chamber
4
Programming / Flow Setting
Battery Level
Indication
Device Activity
Indicator
LED Indicators
The composite gun is designed to display the battery state via the battery
level indicator:
The LED light surrounding the ON/OFF button indicates current charge level
(< 20% charged - Red, > 20% charged - Green).
It is advised to charge the battery when the indication lights are Red.
Charging the Battery
The Phasor™ battery is partially charged when shipped. To charge the battery,
simply connect the micro-USB charger to the USB charging port on the device
handle and plug the power adapter into a standard outlet.
During battery charging, the device activity indicator light will pulse.
Once charging is complete, the device activity indicator will remain blue.
When unplugged from the charger, the device activity indicator turns o and
the device will enter a sleep mode. 5
PHASOR™ OPERATION
Inserting Composite
Snap a composite compule into the end of the device.
Position the compule so that the tip is directly under the LED lens.
• Short Compules: position forward
•Long Compules: position back
NOTE: The device will not operate in the absence
of a composite compule.
COMPOSITE BRAND SETTING 1 SETTING 2 SETTING 3 SETTING 4
3M®*
DENTSPLY®*
Ivoclar®*
Kerr®*
VOCO®*
Coltene®*
Kuraray®*
GC®*
Shofu®*
Heraeus Kulzer®*
Tokuyama®*
Centrix®*
OPTIMAL Setting Compatible Setting DO NOT USE
Composite & Setting Compatibility
The chart below will list the ideal settings for most leading composite brands.
Contact Vista Apex at 877-418-4782 (Toll Free) for additional assistance.
CAUTION: Parts of the composite compule may become hot.
Use caution and avoid touching the top of a hot composite compule.
CAUTION: Do not deviate from the recommended settings.
*3M® is a registered trademark of 3M Company. Dentsply® is a registered trademark of DENTSPLY International. Ivoclar® is a registered trademark of IVOCLAR VIVADENT. Kerr® is a registered trademark of Kerr Corporation.
VOCO® is a registered trademark ofVOCO AMERICA, INC. Coltene® is a registered trademark of COLTENE/WHALEDENT,INC. Kuraray® is a registered trademark of KURARAY CO., LTD. GC® is a registered trademark of GC
Corporation. Shofu® is a registeredtrademark of SHOFU, INC. Heraeus Kulzer® is a registered trademark of Heraeus Kulzer GmbH.Tokuyama® is a registered trademark ofTokuyama Corporation. Centrix® is a registered
trademark of Centrix, Inc.
6

Programming / Flow Setting
Battery Level
Indication
Device Activity
Indicator
LED Indicators
The composite gun is designed to display the battery state via the battery
level indicator:
The LED light surrounding the ON/OFF button indicates current charge level
(< 20% charged - Red, > 20% charged - Green).
It is advised to charge the battery when the indication lights are Red.
Charging the Battery
The Phasor™ battery is partially charged when shipped. To charge the battery,
simply connect the micro-USB charger to the USB charging port on the device
handle and plug the power adapter into a standard outlet.
During battery charging, the device activity indicator light will pulse.
Once charging is complete, the device activity indicator will remain blue.
When unplugged from the charger, the device activity indicator turns o and
the device will enter a sleep mode. 5
PHASOR™ OPERATION
Inserting Composite
Snap a composite compule into the end of the device.
Position the compule so that the tip is directly under the LED lens.
• Short Compules: position forward
•Long Compules: position back
NOTE: The device will not operate in the absence
of a composite compule.
COMPOSITE BRAND SETTING 1 SETTING 2 SETTING 3 SETTING 4
3M®*
DENTSPLY®*
Ivoclar®*
Kerr®*
VOCO®*
Coltene®*
Kuraray®*
GC®*
Shofu®*
Heraeus Kulzer®*
Tokuyama®*
Centrix®*
OPTIMAL Setting Compatible Setting DO NOT USE
Composite & Setting Compatibility
The chart below will list the ideal settings for most leading composite brands.
Contact Vista Apex at 877-418-4782 (Toll Free) for additional assistance.
CAUTION: Parts of the composite compule may become hot.
Use caution and avoid touching the top of a hot composite compule.
CAUTION: Do not deviate from the recommended settings.
*3M® is a registered trademark of 3M Company. Dentsply® is a registered trademark of DENTSPLY International. Ivoclar® is a registered trademark of IVOCLAR VIVADENT. Kerr® is a registered trademark of Kerr Corporation.
VOCO® is a registered trademark ofVOCO AMERICA, INC. Coltene® is a registered trademark of COLTENE/WHALEDENT,INC. Kuraray® is a registered trademark of KURARAY CO., LTD. GC® is a registered trademark of GC
Corporation. Shofu® is a registeredtrademark of SHOFU, INC. Heraeus Kulzer® is a registered trademark of Heraeus Kulzer GmbH.Tokuyama® is a registered trademark ofTokuyama Corporation. Centrix® is a registered
trademark of Centrix, Inc.
6
Reference setting compatibility chart to determine
the appropriate setting per composite brand.
CAUTION: Do not deviate from the recommended settings.
Selecting a Setting
Press & hold to exit.
Device will beep 3 times and shut o.
Short press to toggle between settings.
1. 3.
4.2.
Press & hold to enter programming mode.
This is indicated by ashing yellow lights.
Your setting is now memorized as default.
Start Heating Cycle
Short press to start/stop heating cycle.
The blue lights will ash while heating.
Setting 1-3: 45 seconds
Setting 4: 70 seconds
The blue lights will turn solid when
heating cycle is complete.
The device will automatically shut o
after 3 minutes of sustained heating.
7

Cleaning & Disinfection
The device may be wiped down with a standard disinfectant wipe.
Never spray disinfectant directly onto the device.
Black nosecone is removable and autoclavable.
Between uses, check the lens to ensure it is clean.
A dirty lens will decrease performance.
The Phasor™ is provided non-sterile. There are no special accessories needed
to sterilize the Phasor™ heated composite delivery system.
Quaternary ammonium compound products are recommended
(containing 20% alcohol or less). Wipe, do not spray, solution onto the unit.
Prevent liquids from entering openings on the composite gun unit.
CAUTION: Always use
a protective barrier.
DO NOT AUTOCLAVE HANDPIECE.
REMOVABLE NOSECONES CAN WITHSTAND
AUTOCLAVE - (132°C / 0.22mPA for 3 minutes).
8
Infection Control Measures
CAUTION:
• DO NOT immerse the unit or unit parts in solutions. Use of
solutions other than those recommended may damage plastic
parts and will void product warranty.
• DO NOT use abrasive material such as scouring powder, organic
solvents, or solvent-based cleaning uids. In case of severe
contamination, gently clean the device by using diluted alcohol.
• Store the device in the box if it is not to be used for an extended
period of time.
CAUTION: To prevent cross-contamination, a disposable plastic
sleeve must be used over the Phasor™ with each use. A low-density
polyethylene plastic disposable barrier covers the nose cone of unit
and provides a hermetically sealed barrier between the handpiece
and patients. The disposable barrier limits patient-to-patient
contamination. Discard used barrier sleeves after each patient.
9
Routine Maintenance
Between uses, check the lens to ensure it is clean.
A dirty lens will decrease performance.
1. Insert the hex key provided into
the trigger bolt.
2. Rotate counterclockwise and
remove the trigger bolt once loose.
3. Slide the trigger and spring
assembly apart from the device.
When reassembling, ensure spring
is inserted into the small opening
in the trigger space.
10

Infection Control Measures
CAUTION:
• DO NOT immerse the unit or unit parts in solutions. Use of
solutions other than those recommended may damage plastic
parts and will void product warranty.
• DO NOT use abrasive material such as scouring powder, organic
solvents, or solvent-based cleaning uids. In case of severe
contamination, gently clean the device by using diluted alcohol.
• Store the device in the box if it is not to be used for an extended
period of time.
CAUTION: To prevent cross-contamination, a disposable plastic
sleeve must be used over the Phasor™ with each use. A low-density
polyethylene plastic disposable barrier covers the nose cone of unit
and provides a hermetically sealed barrier between the handpiece
and patients. The disposable barrier limits patient-to-patient
contamination. Discard used barrier sleeves after each patient.
9
Routine Maintenance
Between uses, check the lens to ensure it is clean.
A dirty lens will decrease performance.
1. Insert the hex key provided into
the trigger bolt.
2. Rotate counterclockwise and
remove the trigger bolt once loose.
3. Slide the trigger and spring
assembly apart from the device.
When reassembling, ensure spring
is inserted into the small opening
in the trigger space.
10
6. Thoroughly clean the
plunger space and LED
lens to remove any
composite residue.
NOTE:
• Alcohol may be used
as a cleaning solution.
• DO NOT insert the
brush past the end
of the bristles.
4. Tilt the device forward to allow the
plunger to slide forward and be
removed from the device.
5. With the
nosecone
removed,
clean the
device with
the provided
brush.
11

Battery Removal & Replacement
To remove battery compartment door, press the release button and separate
from device by pulling.
Remove the old battery and replace with the new battery, ensuring that
+/- indicators are properly aligned as indicated on the battery door.
TROUBLESHOOTING GUIDE
If the suggested solutions do not rectify the problem, please call
Vista Apex 877-418-4782 (Toll Free).
PROBLEM POSSIBLE SOLUTION
Composite gun will not turn on 1. Check the unit’s battery indication light.
If red or no light, charge the unit.
2. Remove the battery and check orientation.
Reinsert into the device in proper orientation.
Composite gun is not heating 1. Verify the unit is charged.
2. Verify that an appropriate
temperature is selected.
3. With the handpiece turned o,
and battery removed, inspect the
lens for residual composite.
4. Check expiration date of composite.
Battery will not charge 1. Inspect the USB charging port of any
foreign objects that could interfere with
a proper connection.
2. Remove the battery and check orientation.
Reinsert into the device in proper orientation.
3. Make sure the battery is properly inserted
in the handpiece.
4. Make sure the charger is plugged in and
verify the outlet is receiving power.
Composite compules
are melting
1. Adjust heat setting to lower setting
and try again.
12
TECHNICAL DATA
TECHNICAL INFORMATION PHASOR™ COMPOSITE GUN
Charger Input: 100-240 VAC, 50-60 Hz
Nominal Consumption: 6W max
Manufacturer: GlobTek INC.
Model: GTM46101-1005-USB
Dimensions without blade or cable (LxWxH):
41mm x 71mm x 31.5mm
Mass: 50g
Classication: Protection class II,
Handpiece Battery: 3.6 V nominal, 3000mAh Li-ion, 10.8 Wh
Battery Pack Manufacturer: LG CHEM LTD.
Battery Pack Model: LG-HG2-18650-INR
Dimensions (LxWxH): 150mm x 120mm x 25mm
Mass: 153g
Classication: Type BF,
Intermittent Operation: The device has been designed
solely for short-term operation.
Operating Time: Approximately 2 hrs. fully charged.
Approximately 15 heat cycles on high setting.
Operating Conditions Time to Charge Empty Battery Pack:
Approximately 3 hrs.
Temperature:
10°C - 40°C (59°F - 104°F) Atmospheric Pressure: 697hPa - 1013hPa
10
°C
40°C
697 hPa
1013 hPa
Transport and
Storage Conditions
Temperature: -20°C - 40°C (-4°F - 104°F)
-20
°C
40°C
Relative Humidity: 30% -
90% (non condensing) Atmospheric Pressure: 500hPa - 1400hPa
30%
90% (max)
500 hPa
1400 hPa
13
SYMBOL IDENTIFICATION
Description for additional symbols.
Serial Number Consult instructions for use
Manufacturer Temperature Limitation
Manufacturing Date Humidity Limitation
Class II Medical
Electrical Equipment
Pressure Limitation
Type BF Patient Applied Part Batch Code /
Lot Number
Keep Dry European Representative
Part Number Do not use if seal or packaging
is compromised
This symbol is a mandatory
marking for devices entering
the European market to indicate
conformity with the essential
health and safety requirements
set out in European Directives
CAUTION: U.S. federal law restricts
this device to sale by or on the
order of a dental professional.
Do not reuse This symbol refers to the special
disposal of electrical and electronic
devices in EU countries. Please do
not discard this device in household
garbage. Check the proper means
of disposal in your country at your
community recycling, waste center
or at your dealer. Take care to
dispose of properly.
Warning / Caution Autoclavable up to the
temperature specied
BATTERY DISPOSAL
Batteries contain toxic material and should not be disposed of in landlls
or incinerators. Dispose of depleted batteries as directed by your local solid
waste handling regulations. To dispose of the battery in North America, we
recommend www.call2recycle.com to locate a recycling facility near you.
14

TECHNICAL DATA
TECHNICAL INFORMATION PHASOR™ COMPOSITE GUN
Charger Input: 100-240 VAC, 50-60 Hz
Nominal Consumption: 6W max
Manufacturer: GlobTek INC.
Model: GTM46101-1005-USB
Dimensions without blade or cable (LxWxH):
41mm x 71mm x 31.5mm
Mass: 50g
Classication: Protection class II,
Handpiece Battery: 3.6 V nominal, 3000mAh Li-ion, 10.8 Wh
Battery Pack Manufacturer: LG CHEM LTD.
Battery Pack Model: LG-HG2-18650-INR
Dimensions (LxWxH): 150mm x 120mm x 25mm
Mass: 153g
Classication: Type BF,
Intermittent Operation: The device has been designed
solely for short-term operation.
Operating Time: Approximately 2 hrs. fully charged.
Approximately 15 heat cycles on high setting.
Operating Conditions Time to Charge Empty Battery Pack:
Approximately 3 hrs.
Temperature:
10°C - 40°C (59°F - 104°F) Atmospheric Pressure: 697hPa - 1013hPa
10
°C
40°C
697 hPa
1013 hPa
Transport and
Storage Conditions
Temperature: -20°C - 40°C (-4°F - 104°F)
-20
°C
40°C
Relative Humidity: 30% -
90% (non condensing) Atmospheric Pressure: 500hPa - 1400hPa
30%
90% (max)
500 hPa
1400 hPa
13
SYMBOL IDENTIFICATION
Description for additional symbols.
Serial Number Consult instructions for use
Manufacturer Temperature Limitation
Manufacturing Date Humidity Limitation
Class II Medical
Electrical Equipment
Pressure Limitation
Type BF Patient Applied Part Batch Code /
Lot Number
Keep Dry European Representative
Part Number Do not use if seal or packaging
is compromised
This symbol is a mandatory
marking for devices entering
the European market to indicate
conformity with the essential
health and safety requirements
set out in European Directives
CAUTION: U.S. federal law restricts
this device to sale by or on the
order of a dental professional.
Do not reuse This symbol refers to the special
disposal of electrical and electronic
devices in EU countries. Please do
not discard this device in household
garbage. Check the proper means
of disposal in your country at your
community recycling, waste center
or at your dealer. Take care to
dispose of properly.
Warning / Caution Autoclavable up to the
temperature specied
BATTERY DISPOSAL
Batteries contain toxic material and should not be disposed of in landlls
or incinerators. Dispose of depleted batteries as directed by your local solid
waste handling regulations. To dispose of the battery in North America, we
recommend www.call2recycle.com to locate a recycling facility near you.
14
SAFETY NOTES, WARNINGS
AND PRECAUTIONS
Read all instructions before operating this unit. The Phasor™ heated
composite delivery system emits high intensity light waves and must only be
used as indicated in this manual.
The Phasor™ composite gun is a medical device which is subject to IEC 60601-1
(EN 60601-1) and EMC directives IEC 60601-1-2 (EN 60601-1-2) Edition 4.0,
as well as the 93/42/EEC Medical Device Directive. The composite gun complies
with the relevant EU regulations.
The device has been shipped from the manufacturer in a safe and technically
sound condition. In order to maintain this condition and to ensure risk-free
operation, the notes and regulations in these Instructions for Use have to be
observed. To prevent damage to equipment and risk for patients, users and
third parties, the following safety instructions have to be observed.
WARNING:
• The user should test the product before use to ensure proper
functionality. Test each ow setting with the tooth models provided.
• As with any heavily used medical device, the user needs to ensure
a functional backup is readily available.
• DO NOT keep or position near ammable materials, or materials
that could combust.
• DO NOT look directly into the IR light output when the device is on.
• DO NOT insert ngers, instruments, or other objects into the
handpiece when the battery pack is removed.
• DO NOT autoclave the handpiece, battery, charging cord or stand.
• ONLY heat composite starting at room temperature.
• DO NOT heat composite if it is already at an elevated temperature
from use in the Phasor™ or other warming devices.
• ONLY USE replacement batteries provided by the manufacturer.
• ONLY DISPENSE composite after warming. Not intended to dispense
composite at room temperature or below.
15

CAUTION:
• U.S. Federal law restricts the sale of this device by or on the order of
a healthcare professional. Use of the device is restricted to qualied
and trained personnel only in accordance with the operation
instructions. The manufacturer assumes no liability for any damage
arising from any other or improper use of this device.
• Only use the charger which is provided with the device. The use of
any other charger can result in damage to the device.
• Condensation resulting from the device being transferred from a
cold to a warm environment may be a potential risk. Never begin
operating the device until it has reached the ambient temperature.
• Use only components and accessories listed in the instructions
associated with the device. Failure to do so will void the warranty,
may decrease the performance, and may lead to unsafe operation.
• In order to avoid electric shock, do not introduce any objects into
the device or remove the device enclosure.
• Should you have any reason to suspect the safety of the device to
be compromised, the device must be taken out of operation and
labeled accordingly to prevent third parties from inadvertently using
a possibly defective device. Safety may be compromised, e.g., if the
device malfunctions or is noticeably damaged.
• Keep solvents, ammable liquids, and sources of intense heat away
from the device as they may damage the plastic housing of the
device, the seals, or the operating buttons.
16
OPERATING CONDITIONS AND
SAFETY CONSIDERATION
Heat Generation
The Phasor™ heated composite delivery system has been designed not to
overheat to the point of discomfort or injury during standard operating
durations. However, care should be taken to allow the product to completely
cool between uses (approximately two-three minutes), to ensure overheating
does not occur.
Cool-Down
Phasor™ features a built in fan which will turn on automatically during
operation. The fan will remain on after operation until the device reaches a
lower temperature.
Adverse Reactions
There are no known adverse reactions.
Contraindications
Phasor™ should not be used for any application outside of
composite restorations.
• DO NOT heat composite if it is already at an elevated temperature from
use in the Phasor™ or other warming devices.
• ONLY DISPENSE composite after warming. Not intended to dispense
composite at room temperature or below.
17
VISTA APEX TERMS AND CONDITIONS
OF WARRANTY
The Phasor™ handpiece is warranted to be free from defects under
normal usage conditions for one (1) year of its date of delivery;
the batteries for one (1) year. There is no warranty, expressed or implied,
of merchantability or tness. The manufacturer’s sole obligation under
this warranty is to opt to either repair or replace the defective part(s)
or product. If service must be performed to correct a defect, then
the manufacturer will provide the service at its factory according to
the mutual agreement made in advance.The manufacturer and its
distributors will not accept the return of the product unless the return
is authorized and shipped in accordance with the manufacturer’s
instructions. Contact the local representative of the distributor, or if
purchased directly from the manufacturer for shipping instructions,
a return authorization number, and ARS shipping label. There is no
warranty, remedy or condition, expressed or implied, except as provided
herein. The warranty and remedies contained herein are made by the
manufacturer to the rst buyer for dental use and are in lieu of all other
agreements (expressed or implied), liabilities or remedies for breach of
warranty. Vista Apex shall not be liable for consequential or incidental
damages. No person or distributor is authorized to modify the terms of
this warranty.
This warranty is void if any defect is caused by conditions beyond the
manufacturer’s control, including acts of God, damage resulting from
mishandling, neglect, misuse, improper maintenance, accident or
alteration/repair by anyone other than the manufacturer. The buyer
assumes all liability for any damage caused by improper use of the
product. The manufacturer assumes no liability for the user’s failure to
follow the instructions contained in this manual.
18

OPERATING CONDITIONS AND
SAFETY CONSIDERATION
Heat Generation
The Phasor™ heated composite delivery system has been designed not to
overheat to the point of discomfort or injury during standard operating
durations. However, care should be taken to allow the product to completely
cool between uses (approximately two-three minutes), to ensure overheating
does not occur.
Cool-Down
Phasor™ features a built in fan which will turn on automatically during
operation. The fan will remain on after operation until the device reaches a
lower temperature.
Adverse Reactions
There are no known adverse reactions.
Contraindications
Phasor™ should not be used for any application outside of
composite restorations.
• DO NOT heat composite if it is already at an elevated temperature from
use in the Phasor™ or other warming devices.
• ONLY DISPENSE composite after warming. Not intended to dispense
composite at room temperature or below.
17
VISTA APEX TERMS AND CONDITIONS
OF WARRANTY
The Phasor™ handpiece is warranted to be free from defects under
normal usage conditions for one (1) year of its date of delivery;
the batteries for one (1) year. There is no warranty, expressed or implied,
of merchantability or tness. The manufacturer’s sole obligation under
this warranty is to opt to either repair or replace the defective part(s)
or product. If service must be performed to correct a defect, then
the manufacturer will provide the service at its factory according to
the mutual agreement made in advance.The manufacturer and its
distributors will not accept the return of the product unless the return
is authorized and shipped in accordance with the manufacturer’s
instructions. Contact the local representative of the distributor, or if
purchased directly from the manufacturer for shipping instructions,
a return authorization number, and ARS shipping label. There is no
warranty, remedy or condition, expressed or implied, except as provided
herein. The warranty and remedies contained herein are made by the
manufacturer to the rst buyer for dental use and are in lieu of all other
agreements (expressed or implied), liabilities or remedies for breach of
warranty. Vista Apex shall not be liable for consequential or incidental
damages. No person or distributor is authorized to modify the terms of
this warranty.
This warranty is void if any defect is caused by conditions beyond the
manufacturer’s control, including acts of God, damage resulting from
mishandling, neglect, misuse, improper maintenance, accident or
alteration/repair by anyone other than the manufacturer. The buyer
assumes all liability for any damage caused by improper use of the
product. The manufacturer assumes no liability for the user’s failure to
follow the instructions contained in this manual.
18
RETURN POLICY
Vista Apex will accept for return previously purchased merchandise which is
suitable for resale or was shipped in error by Vista Apex. Merchandise suitable
for resale requires current labeling and unopened non-soiled packaging.
All returns must have prior approval and must be shipped “prepaid”
along with a return authorization form and a copy of the original invoice.
Any products returned that are discontinued, dated, damaged, or opened
could be denied credit or assessed a higher return fee.
Equipment cannot be returned without written authorization from Vista Apex.
Merchandise returned for credit must be received by Vista Apex within
30 days of the original invoice date.
RETURN RESTOCKING POLICY
30 days 15%
31-60 days 25%
60+ days Not Returnable
Any equipment returned within 30 days from the date of the original
shipment from Vista Apex may not be assessed a restocking fee as long as
the merchandise has current labeling and unopened non-soiled packaging.
Unopened equipment returned within 31-60 days from the date of the
original shipment from Vista Apex requires a restocking fee of 25% of the
purchase price, including shipping and handling charges. Any equipment
returned after 60 days from date of the original shipment from Vista Apex
will not be restockable for credit.
• Special orders are not suitable for resale and therefore not returnable
for credit.
• Claims for lost or damaged shipments should be led immediately
with the carrier.
• Claims for overage, shortage, and/or internal damage must be made to
Vista Apex within 10 days of receipt of goods.
19

APPENDIX –
ELECTROMAGNETIC COMPATIBILITY AND
ELECTRICAL SAFETY INFORMATION
The Phasor™ heated composite delivery system is tested according to IEC 60601-1-2,
Edition 4.0.
Medical electrical devices are subject to particular preventive action according to
EMC rules and must be installed and operated according to the EMC guidelines in the
accompanying documents.
Guidance and Manufacturer's Declaration – Electromagnetic Emission
The following tables are guidelines according to the 4th edition of the medical
standard IEC 60601-1-2.
Phasor™ heated composite delivery system is intended for use in the electromagnetic
environment specied below. The customer or the user of the Phasor™ heated
composite delivery system should assure that it is used in such an environment.
EMISSION TEST COMPLIANCE ELECTROMAGNETIC ENVIRONMENT - GUIDANCE
RF emissions CISPR 11 Group 1 Phasor™ uses RF energy only for its internal function. Therefore, its RF emissions are very low and are not likely to
cause any interference in nearby electrical equipment.
RF emissions CISPR 11 Class B
Phasor™ is suitable for use in all establishments, including
domestic establishments and those directly connected to
the public low-voltage power supply network that supplies
buildings used for domestic purposes.
Harmonic emissions IEC
61000-3-2 Complies N/A
Voltage uctuations / icker
emissions IEC 61000-3-3 Complies N/A
Table: According to IEC 60601-1-2, Edition 4.0
Guidance and Manufacturer's Declaration – Electromagnetic Immunity
The Phasor™ heated composite delivery system is intended for use in the
electromagnetic environment specied below. The customer or the user of the
Phasor™ heated composite delivery system should assure that it is used in such
an environment.
IMMUNITY TEST IEC 60601
TEST LEVEL
COMPLIANCE
LEVEL
ELECTROMAGNETIC ENVIRONMENT -
GUIDANCE
Electrostatic
discharge (ESD) IEC
61000-4-2
± 6 kV contact
± 15 kV air ± 6 kV contact ± 15 kV air
Floors should be concrete or ceramic tile. If oors
are covered with synthetic material, the relative
humidity should be at least 30%.
Electric fast transient
/ burst IEC 61000-4-4 ± 2 kV for power supply lines ± 2 kV for power supply lines Mains power quality should be that of typical commercial or dental environment.
Surge IEC
61000-4-4 ± 1 kV line - line ± 2 kV line - earth ± 1 kV line - line No prot. earth Mains power quality should be that of typical commercial or dental environment.
20
Voltage dips, short
interruptions and
voltage variations
on power supply
input line IEC
61000-4-11
<5% UT (>95% dip
in UT) for 0.5 cycle
40% UT (60% dip in
UT) for 5 cycles
70% UT (30% dip in
UT) for 25 cycles
<5% UT (>95% dip
in UT) for 5 sec
<5% UT (>95% dip
in UT) for 0.5 cycle
40% UT (60% dip in
UT) for 5 cycles
70% UT (30% dip in
UT) for 25 cycles
<5% UT (>95% dip
in UT) for 5 sec
Mains power quality should be that of typical
commercial or dental environment. If the user of
the Phasor™ requires continued operation during
power mains interruptions,
it is recommended that the Phasor™
be powered from an uninterruptible
power supply or battery.
Power frequency
(50/60Hz)
magnetic eld
IEC 61000-4-8
3 A/m 3 A/m Power frequency magnetic elds should be at levels characteristic of a typical location in a
typical commercial or dental environment.
Portable and mobile RF communications equipment should not be used closer to
any part of the Phasor™, including cables, than the recommended separation distance
calculated from the equation applicable to the frequency of the transmitter.
Recommended separation distance
Conducted RF
IEC 61000-4-6 3Vrms 150 kHz to 80 MHz 3V d = 0.35 √P
Radiated RF
IEC 61000-4-3 3 V/m 80 MHz to 2.5 GHz 10 V/m
d = 0.35 √P 80 MHz to 800 MHz
d = 0.70 √P 800 MHz to 2.5 GHz
Where P is the maximum output power rating
of the transmitter in watts (W) according to
the transmitter manufacturer and d is the
recommended separation distance in meters (m).
Field strengths from xed RF transmitters,
as determined by an electromagnetic site survey
(a), should be less than the compliance level in
each frequency range (b). Interference may occur
in the vicinity of equipment marked with the
following symbol:
Table: According to IEC 60601-1-2, Edition 4.0
NOTE: UT is the a.c. mains voltage prior to application of the test level.
NOTE: At 80 MHz and 800 MHz, the higher frequency range applies.
NOTE: These guidelines may not apply in all situations. Electromagnetic propagation is aected
by absorption and reection from structures, objects and people.
a - Field strengths from xed transmitters, such as base stations for radio (cellular/cordless)
telephones and land mobile radios, amateur radio, AM and FM radio broadcast and
TV broadcast cannot be predicted theoretically with accuracy. To assess the
electromagnetic environment due to xed RF transmitters, an electromagnetic
site survey should be considered.
If the measured eld strength in the location in which the Phasor™ heated composite delivery
system is used exceeds the applicable RF compliance level above, the Phasor™ should
be observed to verify normal operation. If abnormal performance is observed, additional
measures may be necessary, such as reorienting or relocating the Phasor™ heated composite
delivery system.
b - Over the frequency range 150 kHz to 80 MHz, eld strength should be less than 10 V/m.
IMMUNITY TEST IEC 60601
TEST LEVEL
COMPLIANCE
LEVEL
ELECTROMAGNETIC ENVIRONMENT -
GUIDANCE
21
Recommended Separation Distances Between Portable and Mobile
RF communications equipment and the “Phasor™ Heated Composite
Delivery System”
The Phasor™ heated composite delivery system is intended for use in the
electromagnetic environment in which radiated RF disturbances are controlled.
The customer or the user of the Phasor™ heated composite delivery system can
help prevent electromagnetic interference by maintaining a minimum distance
between portable and mobile RF communications equipment (transmitters) and the
Phasor™ heated composite delivery system as recommended below, according to the
maximum output power of the communication equipment.
Rated Maximum
Output Power of
Transmitter (W)
Separation Distance According To Frequency of Transmitter (m)
150 kHz to 80 MHz
d = 0.35 √P 80 MHz to 800 MHz d = 0.35 √P 800 MHz to 2.5 GHz d = 0.7 √P
0.01 0.035 0.12 0.23
0.1 0.11 0.38 0.73
1 0.35 1.2 2.3
10 1.1 3.8 7.3
100 3.5 12 23
Table: According to IEC 60601-1-2, Edition 4.0
For transmitters rated at a maximum output power not listed above,
the recommended separation distance d in meters (m) can be determined
using the equation applicable to the frequency of the transmitter, where P is the
maximum output power rating of the transmitter in watts (W) according to the
transmitter manufacturer.
NOTE: At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies.
NOTE: These guidelines may not apply in all situations. Electromagnetic propagation is aected
by absorption and reection from structures, objects and people.
22

Voltage dips, short
interruptions and
voltage variations
on power supply
input line IEC
61000-4-11
<5% UT (>95% dip
in UT) for 0.5 cycle
40% UT (60% dip in
UT) for 5 cycles
70% UT (30% dip in
UT) for 25 cycles
<5% UT (>95% dip
in UT) for 5 sec
<5% UT (>95% dip
in UT) for 0.5 cycle
40% UT (60% dip in
UT) for 5 cycles
70% UT (30% dip in
UT) for 25 cycles
<5% UT (>95% dip
in UT) for 5 sec
Mains power quality should be that of typical
commercial or dental environment. If the user of
the Phasor™ requires continued operation during
power mains interruptions,
it is recommended that the Phasor™
be powered from an uninterruptible
power supply or battery.
Power frequency
(50/60Hz)
magnetic eld
IEC 61000-4-8
3 A/m 3 A/m Power frequency magnetic elds should be at levels characteristic of a typical location in a
typical commercial or dental environment.
Portable and mobile RF communications equipment should not be used closer to
any part of the Phasor™, including cables, than the recommended separation distance
calculated from the equation applicable to the frequency of the transmitter.
Recommended separation distance
Conducted RF
IEC 61000-4-6 3Vrms 150 kHz to 80 MHz 3V d = 0.35 √P
Radiated RF
IEC 61000-4-3 3 V/m 80 MHz to 2.5 GHz 10 V/m
d = 0.35 √P 80 MHz to 800 MHz
d = 0.70 √P 800 MHz to 2.5 GHz
Where P is the maximum output power rating
of the transmitter in watts (W) according to
the transmitter manufacturer and d is the
recommended separation distance in meters (m).
Field strengths from xed RF transmitters,
as determined by an electromagnetic site survey
(a), should be less than the compliance level in
each frequency range (b). Interference may occur
in the vicinity of equipment marked with the
following symbol:
Table: According to IEC 60601-1-2, Edition 4.0
NOTE: UT is the a.c. mains voltage prior to application of the test level.
NOTE: At 80 MHz and 800 MHz, the higher frequency range applies.
NOTE: These guidelines may not apply in all situations. Electromagnetic propagation is aected
by absorption and reection from structures, objects and people.
a - Field strengths from xed transmitters, such as base stations for radio (cellular/cordless)
telephones and land mobile radios, amateur radio, AM and FM radio broadcast and
TV broadcast cannot be predicted theoretically with accuracy. To assess the
electromagnetic environment due to xed RF transmitters, an electromagnetic
site survey should be considered.
If the measured eld strength in the location in which the Phasor™ heated composite delivery
system is used exceeds the applicable RF compliance level above, the Phasor™ should
be observed to verify normal operation. If abnormal performance is observed, additional
measures may be necessary, such as reorienting or relocating the Phasor™ heated composite
delivery system.
b - Over the frequency range 150 kHz to 80 MHz, eld strength should be less than 10 V/m.
IMMUNITY TEST IEC 60601
TEST LEVEL
COMPLIANCE
LEVEL
ELECTROMAGNETIC ENVIRONMENT -
GUIDANCE
21
Recommended Separation Distances Between Portable and Mobile
RF communications equipment and the “Phasor™ Heated Composite
Delivery System”
The Phasor™ heated composite delivery system is intended for use in the
electromagnetic environment in which radiated RF disturbances are controlled.
The customer or the user of the Phasor™ heated composite delivery system can
help prevent electromagnetic interference by maintaining a minimum distance
between portable and mobile RF communications equipment (transmitters) and the
Phasor™ heated composite delivery system as recommended below, according to the
maximum output power of the communication equipment.
Rated Maximum
Output Power of
Transmitter (W)
Separation Distance According To Frequency of Transmitter (m)
150 kHz to 80 MHz
d = 0.35 √P 80 MHz to 800 MHz d = 0.35 √P 800 MHz to 2.5 GHz d = 0.7 √P
0.01 0.035 0.12 0.23
0.1 0.11 0.38 0.73
1 0.35 1.2 2.3
10 1.1 3.8 7.3
100 3.5 12 23
Table: According to IEC 60601-1-2, Edition 4.0
For transmitters rated at a maximum output power not listed above,
the recommended separation distance d in meters (m) can be determined
using the equation applicable to the frequency of the transmitter, where P is the
maximum output power rating of the transmitter in watts (W) according to the
transmitter manufacturer.
NOTE: At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies.
NOTE: These guidelines may not apply in all situations. Electromagnetic propagation is aected
by absorption and reection from structures, objects and people.
22
NOTES
______________________________________________________
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______________________________________________________
______________________________________________________
______________________________________________________
______________________________________________________
______________________________________________________
______________________________________________________
23

NOTES
______________________________________________________
______________________________________________________
______________________________________________________
______________________________________________________
______________________________________________________
______________________________________________________
______________________________________________________
______________________________________________________
______________________________________________________
______________________________________________________
______________________________________________________
______________________________________________________
______________________________________________________
______________________________________________________
______________________________________________________
24
408800
Ce manuel doit être lu attentivement et compris avant
d’utiliser le système de chauage composite Phasor™.
Pack de procédures assemblé par :
Inter-Med, Inc.
2200 South St.
Racine, WI 53404 U.S.A.
Tel.: [phone]
Fax: [phone]
Nº gratuit: [phone]
www.vistaapex.com
Emergo Europe
Prinsessegracht 20
2514 AP The Hague
The Netherlands
Rx ONLY
Breveté# 10,589,829
MANUEL D’UTILISATION
À utiliser uniquement par des professionnels qualiés
TABLE DES MATIÈRES
Introduction .................................................................................... 27
Bienvenue chez Vista Apex’s Phasor™ ............................................................................ 27
Contenu du kit Phasor™ ...................................................................................................... 27
Utilisation prévue / Indications d’utilisation ............................................................... 28
Conguration et utilisation de Phasor™ ....................................... 28
Déballage du conteneur .................................................................................................... 28
Introduction ............................................................................................................................ 28
Témoins LED ............................................................................................................................ 29
Chargement de la batterie ................................................................................................. 29
Opération Phasor™ ......................................................................... 30
Insertion de composite ....................................................................................................... 30
Compatibilité composite et réglage ............................................................................... 30
Sélection d’un paramètre ................................................................................................... 31
Démarrer le cycle de chauage ....................................................................................... 31
Nettoyage & Désinfection ...................................................................................................32
Mesures de contrôle des infections ................................................................................ 33
Entretien habituel ........................................................................................................... 34-35
Retrait et remplacement de la batterie ......................................................................... 36
Guide de dépannage ...................................................................... 36
Données techniques ....................................................................... 37
Identication des symboles ........................................................... 38
Élimination de la batterie ............................................................... 38
Notes de sécurité, avertissements et précautions .................. 39-40
Conditions d’exploitation et considérations de sécurité ............. 41
Production de chaleur ......................................................................................................... 41
Refroidissement ..................................................................................................................... 41
Eets indésirables ................................................................................................................. 41
Contre-indications ................................................................................................................ 41
Conditions générales de garantie ................................................. 42
des produits dentaires Vista Apex
Politique de retour / ........................................................................ 43
Politique de retour de réapprovisionnement
Annexe - Informations sur la compatibilité ............................ 44-46
électromagnétique et la sécurité électrique
26

408800
Ce manuel doit être lu attentivement et compris avant
d’utiliser le système de chauage composite Phasor™.
Pack de procédures assemblé par :
Inter-Med, Inc.
2200 South St.
Racine, WI 53404 U.S.A.
Tel.: [phone]
Fax: [phone]
Nº gratuit: [phone]
www.vistaapex.com
Emergo Europe
Prinsessegracht 20
2514 AP The Hague
The Netherlands
Rx ONLY
Breveté# 10,589,829
MANUEL D’UTILISATION
À utiliser uniquement par des professionnels qualiés
TABLE DES MATIÈRES
Introduction .................................................................................... 27
Bienvenue chez Vista Apex’s Phasor™ ............................................................................ 27
Contenu du kit Phasor™ ...................................................................................................... 27
Utilisation prévue / Indications d’utilisation ............................................................... 28
Conguration et utilisation de Phasor™ ....................................... 28
Déballage du conteneur .................................................................................................... 28
Introduction ............................................................................................................................ 28
Témoins LED ............................................................................................................................ 29
Chargement de la batterie ................................................................................................. 29
Opération Phasor™ ......................................................................... 30
Insertion de composite ....................................................................................................... 30
Compatibilité composite et réglage ............................................................................... 30
Sélection d’un paramètre ................................................................................................... 31
Démarrer le cycle de chauage ....................................................................................... 31
Nettoyage & Désinfection ...................................................................................................32
Mesures de contrôle des infections ................................................................................ 33
Entretien habituel ........................................................................................................... 34-35
Retrait et remplacement de la batterie ......................................................................... 36
Guide de dépannage ...................................................................... 36
Données techniques ....................................................................... 37
Identication des symboles ........................................................... 38
Élimination de la batterie ............................................................... 38
Notes de sécurité, avertissements et précautions .................. 39-40
Conditions d’exploitation et considérations de sécurité ............. 41
Production de chaleur ......................................................................................................... 41
Refroidissement ..................................................................................................................... 41
Eets indésirables ................................................................................................................. 41
Contre-indications ................................................................................................................ 41
Conditions générales de garantie ................................................. 42
des produits dentaires Vista Apex
Politique de retour / ........................................................................ 43
Politique de retour de réapprovisionnement
Annexe - Informations sur la compatibilité ............................ 44-46
électromagnétique et la sécurité électrique
26
IMPORTANT !
REMARQUE! Avant l’installation et la mise en service de l’appareil,
veuillez lire attentivement ces instructions. Comme pour tous les appareils
techniques, le bon fonctionnement de cet appareil, en toute sécurité,
dépend du respect par l’utilisateur des procédures de sécurité standard,
ainsi que de celles de sécurité, présentées dans ce mode d’emploi.
INTRODUCTION
Bienvenue chez Vista Apex’s Phasor™
Félicitations quant à votre décision d’intégrer le système d’administration de
composite chauant Phasor™ dans votre cabinet. Ce dispositif en instance de
brevet est le premier du genre, utilisant la technologie NIR (proche infrarouge)
pour réchauer rapidement des compules composites hautement chargés.
Grâce à une simple pression sur un bouton, Phasor™ est capable de chauer
le matériau composite à 150°F en quelques secondes et de maintenir cette
température tout au long de la procédure.
Le réchauement du composite réduit considérablement la viscosité du matériau,
ce qui se traduit par une meilleure adaptation, une réduction des vides et des
microfuites et une meilleure profondeur de durcissement. Les matériaux restent
hautement sculptables, non collants et faciles à façonner pendant la manipulation.
Le site Web des produits Vista Apex, www.vistaapex.com, fournit également
des informations sur les nouveaux produits, les accessoires et une assistance
pédagogique pour vous et votre personnel professionnel. Si vous avez des
questions concernant l’utilisation du Phasor™, veuillez appeler notre service
à la clientèle sans frais au [phone].
Contents of the Phasor™ Kit
Le Phasor™ est composé des éléments suivants :
(1) Pièce manuelle
(3) Embouts nasaux amovibles
(100) Manchons jetables
(1) Support
(1) Alimentation
(1) Kit d’entretien de l’appareil
(1) Mode d’emploi
(1) Carte de garantie
REMARQUE: TOUS LES
COMPOSANTS SONT NON STÉRILES.
Alimentation:
GlobTek, Inc.
186 Veterans Drive
Northvale, NJ 07647 U.S.A.
Tel.: [phone]
Tous les autres articles :
Inter-Med, Inc.
2200 South St.
Racine, WI 53404 U.S.A.
Tel.: [phone]
27

Utilisation prévue / Indications d’utilisation
Chauage et distribution de matériaux composites dentaires.
CONFIGURATION ET UTILISATION
DE PHASOR™
Déballage du conteneur
Aucune assistance particulière n’est requise pour déballer et assembler le Phasor™.
Pour toute question, allez sur www.vistaapex.com ou appelez Vista Apex au
[phone] (Nº gratuit).
L’emballage doit être inspecté à l’arrivée pour détecter des dommages dus
au transport. Un emballage endommagé pouvant indiquer la présence
d’un produit dangereux, celui-ci ne doit pas être utilisé avant d’avoir été
soigneusement inspecté. Si le colis ou le produit sont endommagés, veuillez
contacter Vista Apex au [phone] (sans frais) ainsi que le service de
livraison pour déposer une réclamation.
Introduction
Veuillez vous référer à l’image ci-dessous pour vous familiariser avec le Phasor™.
Déclencheur de
distribution
Compartiment
Programmation /
Bouton
d’alimentation
Port de
charge
Amovible
Nosecone
Snap-Fit Compule
Chambre de
chauage
28
Programmation /
Réglage de ux
Niveau de la
batterie
Indication
Activité de
l’appareil
Indicateur
Témoins LED
Le pistolet composite est conçu pour acher l’état de la batterie via
l’indicateur de niveau de batterie:
Le voyant LED entourant le bouton ON/OFF indique le niveau de charge
actuelle (< 20% chargé - Rouge, > 20% chargé - Vert).
Il est conseillé de charger la batterie lorsque les voyants lumineux sont en Rouge.
Chargement de la batterie
La batterie Phasor™ est partiellement chargée lors de l’expédition. Pour la
recharger, il sut de brancher le chargeur micro-USB au port de charge USB sur
la poignée de l’appareil et l’adaptateur sur secteur dans une prise standard.
Pendant le chargement de la batterie, le voyant d’activité de l’appareil clignote.
Une fois la charge terminée, l’indicateur d’activité de l’appareil restera bleu.
Lorsqu’il est débranché du chargeur, l’indicateur d’activité de l’appareil s’éteint
et l’appareil passe alors en mode veille. 29
OPÉRATION PHASOR™
Insertion de composite
Insérez une compule composite à l’extrémité de l’appareil. Disposez-la
de manière à ce que la pointe soit directement sous la lentille LED.
• Compules courtes: position avant
• Compules longues: position arrière
REMARQUE: L’appareil ne fonctionnera pas en l’absence
d’une compule composite.
COMPOSITE MARQUE PARAMÈTRE 1 PARAMÈTRE 2 PARAMÈTRE 3 PARAMÈTRE 4
3M®*
DENTSPLY®*
Ivoclar®*
Kerr®*
VOCO®*
Coltene®*
Kuraray®*
GC®*
Shofu®*
Heraeus Kulzer®*
Tokuyama®*
Centrix®*
OPTIMAL Paramètre Paramètre compatible NE PAS UTILISER
Compatibilité composite et réglage
Le tableau ci-dessous répertorie les paramètres idéaux pour la plupart des
grandes marques de composites. Contactez Vista Apex au [phone]
(sans frais) pour obtenir de l’aide supplémentaire.
ATTENTION: Certaines parties de la compule composite peuvent devenir
chaudes. Soyez prudent et évitez de toucher le dessus d’une compule composite.
ATTENTION: Ne pas dévier des réglages recommandés.
*3M® est une marque déposée de 3M Company.Dentsply® est une marque déposée de DENTSPLY International. Ivoclar®est une marque déposée d’IVOCLAR VIVADENT.Kerr® est une marque déposée de Kerr Corporation.
VOCO® est une marque déposée deVOCO AMERICA, INC. Coltene® est une marque déposée de COLTENE/WHALEDENT, INC. Kuraray®est une marque déposée de KURARAY CO., LTD. GC® est une marque déposée de GC
Corporation. Shofu® est une marque déposée de SHOFU,INC. Heraeus Kulzer® est une marque déposée de Heraeus Kulzer GmbH. Tokuyama® est une marque déposée de Tokuyama Corporation. Centrix®est une marque
déposée de Centrix, Inc.
30

Programmation /
Réglage de ux
Niveau de la
batterie
Indication
Activité de
l’appareil
Indicateur
Témoins LED
Le pistolet composite est conçu pour acher l’état de la batterie via
l’indicateur de niveau de batterie:
Le voyant LED entourant le bouton ON/OFF indique le niveau de charge
actuelle (< 20% chargé - Rouge, > 20% chargé - Vert).
Il est conseillé de charger la batterie lorsque les voyants lumineux sont en Rouge.
Chargement de la batterie
La batterie Phasor™ est partiellement chargée lors de l’expédition. Pour la
recharger, il sut de brancher le chargeur micro-USB au port de charge USB sur
la poignée de l’appareil et l’adaptateur sur secteur dans une prise standard.
Pendant le chargement de la batterie, le voyant d’activité de l’appareil clignote.
Une fois la charge terminée, l’indicateur d’activité de l’appareil restera bleu.
Lorsqu’il est débranché du chargeur, l’indicateur d’activité de l’appareil s’éteint
et l’appareil passe alors en mode veille. 29
OPÉRATION PHASOR™
Insertion de composite
Insérez une compule composite à l’extrémité de l’appareil. Disposez-la
de manière à ce que la pointe soit directement sous la lentille LED.
• Compules courtes: position avant
• Compules longues: position arrière
REMARQUE: L’appareil ne fonctionnera pas en l’absence
d’une compule composite.
COMPOSITE MARQUE PARAMÈTRE 1 PARAMÈTRE 2 PARAMÈTRE 3 PARAMÈTRE 4
3M®*
DENTSPLY®*
Ivoclar®*
Kerr®*
VOCO®*
Coltene®*
Kuraray®*
GC®*
Shofu®*
Heraeus Kulzer®*
Tokuyama®*
Centrix®*
OPTIMAL Paramètre Paramètre compatible NE PAS UTILISER
Compatibilité composite et réglage
Le tableau ci-dessous répertorie les paramètres idéaux pour la plupart des
grandes marques de composites. Contactez Vista Apex au [phone]
(sans frais) pour obtenir de l’aide supplémentaire.
ATTENTION: Certaines parties de la compule composite peuvent devenir
chaudes. Soyez prudent et évitez de toucher le dessus d’une compule composite.
ATTENTION: Ne pas dévier des réglages recommandés.
*3M® est une marque déposée de 3M Company.Dentsply® est une marque déposée de DENTSPLY International. Ivoclar®est une marque déposée d’IVOCLAR VIVADENT.Kerr® est une marque déposée de Kerr Corporation.
VOCO® est une marque déposée deVOCO AMERICA, INC. Coltene® est une marque déposée de COLTENE/WHALEDENT, INC. Kuraray®est une marque déposée de KURARAY CO., LTD. GC® est une marque déposée de GC
Corporation. Shofu® est une marque déposée de SHOFU,INC. Heraeus Kulzer® est une marque déposée de Heraeus Kulzer GmbH. Tokuyama® est une marque déposée de Tokuyama Corporation. Centrix®est une marque
déposée de Centrix, Inc.
30
Tableau de compatibilité des paramètres de référence pour
déterminer le bon réglage par marque de composite.
Sélection d’un paramètre
Appuyez et restez appuyé pour quitter.
L’appareil émettra 3 bips et s’éteindra.
Appuyez rapidement pour basculer entre
les paramètres.
1. 3.
4.2.
Appuyez et maintenez enfoncé pour entrer
dans le mode de programmation. Ceci est
indiqué par des feux jaunes clignotants.
Votre réglage est maintenant
mémorisé par défaut.
Démarrer le cycle de chauage
Appuyez brièvement pour démarrer/
arrêter le cycle de chauage. Les témoins
bleus clignoteront pendant le chauage.
Réglage 1 à 3: 45 secondes
Réglage 4: 70 secondes
Les témoins bleus s’allumeront lorsque
le cycle de chauage sera terminé.
L’appareil s’éteindra automatiquement
après 3 minutes de chauage constant.
ATTENTION: Ne vous écartez pas des paramètres recommandés.
31

Nettoyage & Désinfection
On peut essuyer cet appareil avec une lingette désinfectante normale.
Ne vaporisez jamais de désinfectant directement sur l’appareil.
L’embout noir est amovible et autoclavable.
Entre chaque utilisation, vériez l’objectif pour
vous assurer qu’il soit bien propre. Un objectif sale
réduirait les performances.
Le Phasor™ est fourni non stérile. Aucun accessoire spécial n’est nécessaire
pour stériliser le système d’administration de composite chauant Phasor™.
Les produits composés d’ammonium quaternaire sont recommandés
(contenant maximum 20 % d’alcool). Étalez la solution, sans la vaporiser pas,
sur l’appareil. Empêchez les liquides de pénétrer dans les ouvertures de l’unité
de pistolet composite.
NE PAS AUTOCLAVER LA PIÈCE.
LES NEZS AMOVIBLES PEUVENT RÉSISTER À
L’AUTOCLAVE - (132°C / 0,22mPA pendant 3 minutes).
ATTENTION:
Utilisez toujours une
barrière de protection.
32
ATTENTION:
• NE PAS immerger l’unité ou les pièces de l’unité dans
des solutions. L’utilisation de solutions autres que celles
recommandées pouvant endommager les pièces en plastique,
cela annulera la garantie du produit.
• NE PAS utiliser de matériaux abrasifs tels que de la poudre à
récurer, des solvants organiques ou des liquides de nettoyage à
base de solvants. En cas de contamination importante, nettoyez
délicatement l’appareil avec de d’alcool dilué.
• Rangez l’appareil dans sa boîte si vous prévoyez de ne pas
l’utiliser pendant longtemps.
Mesures de contrôle des infections
ATTENTION: Pour éviter la contamination mutuelle, il est
recommandé d’utiliser un manchon en plastique jetable sur le
Phasor™ à chaque utilisation. Une barrière jetable en plastique
polyéthylène basse densité recouvre l’embout de l’unité et fournit
une barrière hermétiquement scellée entre la pièce et les patients.
Elle sert à prévenir la contamination entre les patients. Jeter les
manchons barrières usagés après chaque patient.
33
Entretien habituel
Entre chaque utilisation, vériez la lentille pour vous assurer qu’elle est propre.
Un objectif sale diminuera les performances.
1. Insérez la clé hexagonale fournie
dans le boulon de détente.
2. Tournez dans le sens inverse des
aiguilles d’une montre et retirez le
boulon de détente une fois desserré.
3. Faites glisser l’ensemble déclencheur
et ressort en dehors de l’appareil.
Lors du remontage, veillez à ce que le
ressort soit bien inséré dans la petite
fente d’ouverture de déclenchement.
34

ATTENTION:
• NE PAS immerger l’unité ou les pièces de l’unité dans
des solutions. L’utilisation de solutions autres que celles
recommandées pouvant endommager les pièces en plastique,
cela annulera la garantie du produit.
• NE PAS utiliser de matériaux abrasifs tels que de la poudre à
récurer, des solvants organiques ou des liquides de nettoyage à
base de solvants. En cas de contamination importante, nettoyez
délicatement l’appareil avec de d’alcool dilué.
• Rangez l’appareil dans sa boîte si vous prévoyez de ne pas
l’utiliser pendant longtemps.
Mesures de contrôle des infections
ATTENTION: Pour éviter la contamination mutuelle, il est
recommandé d’utiliser un manchon en plastique jetable sur le
Phasor™ à chaque utilisation. Une barrière jetable en plastique
polyéthylène basse densité recouvre l’embout de l’unité et fournit
une barrière hermétiquement scellée entre la pièce et les patients.
Elle sert à prévenir la contamination entre les patients. Jeter les
manchons barrières usagés après chaque patient.
33
Entretien habituel
Entre chaque utilisation, vériez la lentille pour vous assurer qu’elle est propre.
Un objectif sale diminuera les performances.
1. Insérez la clé hexagonale fournie
dans le boulon de détente.
2. Tournez dans le sens inverse des
aiguilles d’une montre et retirez le
boulon de détente une fois desserré.
3. Faites glisser l’ensemble déclencheur
et ressort en dehors de l’appareil.
Lors du remontage, veillez à ce que le
ressort soit bien inséré dans la petite
fente d’ouverture de déclenchement.
34
6. Nettoyez soigneusement
l’espace du piston et la
lentille LED pour éliminer
tout résidu de composite.
REMARQUE:
• L’alcool peut être utilisé
comme solution de
nettoyage.
• NE PAS insérer la brosse
au-delà de l’extrémité
des poils.
4. Inclinez l’appareil vers l’avant pour
permettre au piston de glisser vers
l’avant et d’être retiré de l’appareil.
5. Une fois
le cône de
nez enlevé,
nettoyez
l’appareil
avec la
brosse
fournie.
35

Retrait et remplacement de la batterie
Pour retirer le couvercle du compartiment à piles, appuyez sur le bouton de
déverrouillage et séparez-le de l’appareil en tirant dessus.
Retirez l’ancienne batterie et remplacez-la par la nouvelle, en veillant à ce que les
indicateurs +/- soient bien alignés comme indiqué sur le couvercle de la batterie.
GUIDE DE DÉPANNAGE
Si les solutions suggérées ne corrigent pas le problème, veuillez appeler
Vista Apex [phone] (Nº gratuit).
PROBLÈME SOLUTION ÉVENTUELLE
Le pistolet composite
ne s’allume pas
1. Vériez le voyant d’indication de la batterie de l’appareil.
S’il est rouge ou éteint, chargez l’appareil.
2. Retirez la batterie et vériez son orientation.
Réinsérez-la dans l’appareil dans le bon sens.
Le pistolet composite
ne chaue pas
1. Vériez que l’unité est chargée.
2. Vériez que la bonne température soit sélectionnée.
3. Retirez la batterie une fois la pièce éteinte, puis inspectez
la lentille pour détecter les composites résiduels.
4. Vériez la date de péremption du composite.
La batterie ne
se charge pas
1. Inspectez le port de chargement USB pour éviter toute
interférence d’objet étranger avec une bonne connexion.
2. Retirez la batterie et vériez son orientation.
Réinsérez-la dans l’appareil dans le bon sens.
3. Vériez qu’elle soit bien insérée dans la pièce.
4. Assurez-vous que le chargeur soit bien branché
et la prise sous tension.
Les compules
composites fondent
1. Réglez le réglage de la chaleur sur
le réglage inférieur et réessayez.
36
DONNÉES TECHNIQUES
INFORMATIONS TECHNIQUES PHASOR™ COMPOSITE GUN
Chargeur Entrée: 100-240 VAC, 50-60 Hz
Consommation nominale: 6W maximum
Fabricant: GlobTek INC.
Modèle: GTM46101-1005-USB
Dimensions sans lame ni câble (LxlxH):
41mm x 71mm x 31.5mm
Masse: 50g
Classication: Classe de protection II,
Pièce manuelle Batterie: 3,6 V nominal, 3000 mAh Li-ion, 10,8 Wh
Fabricant de la batterie: LG CHEM LTD.
Modèle de la batterie: LG-HG2-18650-INR
Dimensions (LxlxH): 150mm x 120mm x 25mm
Masse: 153g
Classication: Type BF,
Fonctionnement intermittent: L’appareil a été conçu
uniquement pour un fonctionnement à court terme.
Temps de fonctionnement: Environ 2h pour une recharge
complète. Environ 15 cycles de chaleur à réglage élevé.
Conditions
de fonctionnement
Temps de charge de la batterie vide:
Environ 3 heures
Température:
10°C - 40°C (59°F - 104°F) Pression atmosphérique: 697hPa - 1013hPa
10
°C
40°C
697 hPa
1013 hPa
Conditions de transport
et de stockage
Température: -20°C - 40°C (-4°F - 104° F)
-20
°C
40°C
Humidité relative:
30% - 90% (sans condensation) Pression atmosphérique: 500hPa - 1400hPa
30%
90% (max)
500 hPa
1400 hPa
37
IDENTIFICATION DES SYMBOLES
Description des autres symboles.
Nº de série Suivez le mode d’emploi.
Manufacturer Limitation de température
Date de fabrication Limitation d’humidité
Isolation électrique
protégée de classe II
Atmosphérique
Limitation de pression
Pièce appliquée de type BF Code de lot / Numéro de lot
Garder au sec Représentant Européen
Nº de pièce Ne pas utiliser si scellé ou
emballage est compromis
Ce symbole est un marquage
obligatoire pour les dispositifs entrant
sur le marché européen an d’indiquer
la conformité aux exigences essentielles
de santé et de sécurité énoncées dans
les directives européennes.
PRUDENCE: La loi fédérale américaine
limite la vente de cet appareil par ou
sur ordre d’un professionnel dentaire.
Ne pas réutiliser Ce symbole fait référence à l’élimination
spéciale des appareils électriques et
électroniques dans les pays de l’UE.
Veuillez ne pas jeter cet appareil dans
les ordures ménagères.Vériez les
moyens d’élimination appropriés dans
votre pays auprès de votre centre de
recyclage communautaire, de votre
centre de gestion des déchets ou de
votre revendeur. Prenez soin de vous en
débarrasser correctement.
Avertissement / Prudence Autoclavable jusqu’au
température spéciée
ÉLIMINATION DE LA BATTERIE
Les batteries contenant des matières toxiques, elles ne doivent pas être
jetées dans des décharges ou des incinérateurs. Jetez les batteries vides,
conformément aux réglementations locales en matière de traitement des
déchets solides.
38