Vista Apex pinkwave 90734 User manual

Procedure Pack Assembled by:
Inter-Med, Inc.
2200 South St.
Racine, WI 53404 U.S.A.
Tel.: +1-262-636-9755
Fax: +1-262-636-9760
Toll Free: +1-877-418-4782
Rx ONLY
91037-I-AP-MUL (3)
User’s Manual
For use by qualied professionals only.
This manual must be read thoroughly and
understood prior to using the PinkWave™ Curing Light.
90734

TABLEOFCONTENTS
Introduction ............................................................................................. 3
Welcome to PinkWave™ ........................................................................................................................... 3
Contents of the PinkWave™ Curing Light Kit ................................................................................... 3
Intended Use / Indications for Use ...................................................................................................... 4
PinkWave™ Set-Up and Use ..................................................................... 4
Unpacking the Container ........................................................................................................................ 4
Introduction to the PinkWave™ ............................................................................................................ 4
Attaching/Detaching the Battery Pack to the Handpiece ........................................................... 5
Attaching and Removing the Barrier Sleeve .................................................................................... 5
Using the Autoclavable Light Shields ................................................................................................. 5
Charging the Battery Pack ...................................................................................................................... 6
PinkWave™ Operation ............................................................................. 7
Selecting Your Curing Mode .................................................................................................................. 7
Quick Curing Guide ................................................................................................................................... 7
Transillumination Mode ........................................................................................................................... 8
Disinfection / Sterilization ....................................................................................................................... 8
Infection Control Measures .................................................................................................................... 9
Routine Maintenance ............................................................................................................................... 9
Troubleshooting Guide ........................................................................... 9
Technical Data ........................................................................................ 10
Symbol Identication ........................................................................... 11
Battery Pack Disposal ............................................................................ 11
Safety Notes,Warnings and Precautions ....................................... 12-14
Operating Conditions and Safety Consideration ................................ 14
Heat Generation ....................................................................................................................................... 14
Safety Eyewear .......................................................................................................................................... 15
Vista ApexTerms and Conditions ofWarranty .................................... 15
Return Policy .......................................................................................... 16
Appendix – Electromagnetic Compatibility ................................. 17-19
and Electrical Safety Information
2

INTRODUCTION
WelcometoPinkWave™
Congratulations on your decision to incorporate the PinkWave™ Curing Light into your
practice.Vista Apex's PinkWave™ Curing Light uses multiple wavelengths (375-900nm) to
cure mostly all polymerizable dental materials, making it one of the most versatile curing
lights on the market.The PinkWave™ will greatly enhance the way you cure light cured
dental materials, and is lightweight, easy to use, and most importantly clinically eective.
Our website,vistaapex.com,provides information onnewproducts,accessories, andeducational
assistanceforyou andyour professionalsta.If you haveanyquestionsregardingtheuseofthe
PinkWave™,pleasecallourcustomerservicedepartmentat877-273-9123(TollFree).
ContentsofthePinkWave™CuringLightKit
The PinkWave™ Curing Light Kit is composed of the following:
(1) Cordless handpiece
(1) Charging base
(100) Disposable barrier sleeves
(5) Autoclavable Light Shields
(1) Charging cord
(1) Battery pack
(1) Instructions for Use
(3) Protective Eyewear* (provided separately with each kit)
NOTE: All components are non-sterile.
* The PinkWave™ Paddle can be used instead of
the Protective Eyewear provided with this kit.
IMPORTANT!
PLEASENOTE! 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 specic safety
recommendations presented in these Operating Instructions.
NOTE: According to the EU Medical Devices Regulation, users / patients are obliged
to report serious events with a medical device to the manufacturer and to
the competent authority of the country in which they occurred.
Inter-Med,Inc.
2200 South St.
Racine, WI 53404 U.S.A.
Tel.:+1-262-636-9755
Fax: +1-262-636-9760
Toll Free: +1-877-418-4782
www.vistaapex.com
All Procedure Pack Components Manufactured by:
Emergo Europe
Prinsessegracht 20
2514 AP The Hague
The Netherlands
3

IntendedUse/IndicationsforUse
Source of illumination for curing photo-activated dental restorative materials
and adhesives.
PINKWAVE™SETUPANDUSE
UnpackingtheContainer
No special assistance is required to unpack and assemble the PinkWave™.
If you have questions or concerns, please visit vistaapex.com or callVista 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 contactVista Apex at 877-418-4782 (Toll Free), as well as the delivery service to
le a complaint.
IntroductiontothePinkWave™
Please reference the image below to familiarize yourself with the PinkWave™.
ON/OFF Button
Battery Pack
Curing Light
Anti-Rotation Pins
Mode
Indicators
ON/OFF Button
Mode
Button Battery
Indicator
4

Attaching/DetachingtheBatteryPacktotheHandpiece
1. Insert the battery pack into the handpiece. Allow the threads to catch onto each
other and then screw on clockwise.
2. When the battery pack and handpiece are correctly screwed in, the unit will beep
multiple times.
3. NOTE: The battery pack is threaded and can only be inserted into the handpiece in
one orientation!The battery pack should be easy to insert.
UsingtheAutoclavableLightShields
1. Slide light shield over the barrier sleeve and head of PinkWave™.
2. Light shield opening should be facing the same way as the lens.
3. Light shield should be secured on the device and replicate the
image below.
AttachingandRemovingtheBarrierSleeve
1. Insert the head of the PinkWave™ Curing Light into the opening on the bottom of
the barrier sleeve.
2. Slide the barrier sleeve onto the PinkWave™ Curing Light to cover the entire device.
3. After use, peel o and dispose of the barrier sleeve.
NOTE: Only PinkWave™ Disposable Barrier Sleeves should be used on the
PinkWave™ Curing Light. Barrier sleeves are for single use only.
NOTE: DO NOT operate PinkWave™ without the Autoclavable Light Shield,
and either theVista Apex Protective Eyewear or PinkWave™ Paddle.
5

ChargingtheBatteryPack
1. The PinkWave™ battery packs are partially charged when shipped. Before you turn on
and start using the device, you must insert the battery pack into the handpiece and
fully charge the battery pack before using it for the rst time.The battery pack will be
fully charged within three hours.
2. When the battery pack is charging, the light on the charging base will pulsate.
Once charging is complete, the light on the charging base will stop pulsating
and remain lit.
The handpiece is designed to display the battery state to the user via the
battery indicator light.
• When the battery pack is greater than 33% charged the indication lights
will be solid Green during use.
• When the battery pack is less than 33% charged, the light will blink Red during use,
indicating the handpiece needs to be charged as soon as possible. Once the blinking
Red light comes on, you will have approximately 20 curing cycles left before light is
completely dead.
• When the handpiece is not in use, the induction charging base securely stores and
charges the PinkWave™ unit.
Pulsating
Pink Light
CHARGING
Solid
Pink Light
FULLY
CHARGED
6

PINKWAVE™OPERATION
SelectingYourCuringMode
1. The curing modes are selected via the button on the top of the device.
2. Toggle through modes by pressing the mode button.
3. The current mode will light up bright pink when it has been selected.
This setting will remain the default setting until a new setting is selected.
4. On standard and ramp mode, the light will beep once at 5 seconds,
twice at 10 seconds and three times at 15 seconds.
The gure below illustrates the light position based on the current mode.
QuickCuringGuide
Standard Mode Ramp Mode Boost Mode
Irradiance (mW/cm2)>1515 >1515 >1720
Per 2 mm Layer One 10s cure One 20s cure One 3s cure
Final Cure One 20s cure One 20s cure Two 3s cures
NOTE: Curing time may need to be adjusted due to composite, shade, depth of layer
if over 2mm.
NOTE: These are default curing durations for the PinkWave™ Curing Light.
Follow composite / dental material manufacturer’s guidelines for required
curing durations and irradiance values.
NOTE: Place the PinkWave™ Curing Light as close as possible to dental material.
Irradiance rapidly decreases with increasing distance.
NOTE: Software will automatically turn the PinkWave™ handpiece o if left on
for two continuous minutes in white light / transilluminator mode.
NOTE: Software does not allow for the handpiece to be used when in the charging base.
NOTE: Setting is memorized as
default until charged.
3B 3-second Boost Mode
20R 20-second Ramp Mode
20S 20-second Standard Mode
All Transilluminator
3B 20R 20S Transilluminator
= Mode selected
7

TransilluminationMode
The transillumination mode can be executed by toggling through modes until all lights are
illuminated and pressing the ON/OFF button.The transillumination light is turned o the
same way, by pressing the ON/OFF button.
Disinfection/Sterilization
The PinkWave™ Curing Light is provided non-sterile.There are not any special accessories
needed to sterilize the PinkWave™ Curing Light parts.
Clean thePinkWave™ Curing Lightand LightShieldswithan approved surface disinfectant
solution suchasa quaternary ammoniumcompoundproduct thatcontains20%alcoholor less.
Wipe,do notspray,solutionandfollowthemanufacturer’scleaningrecommendations.
Preventliquidsfromenteringopeningson theunit.
For Protective Eyewear: Clean Protective Eyewear lens with water only. Use a soft cotton
or microber cloth and gently pat lens dry. Do not use abrasive cleaning compounds,
solvents, ammonia or alkaline cleaners.
For PinkWave™ Paddle: DO NOT autoclave the paddle. Autoclaving the paddle may cause
damage. For cleaning the paddle in between patients, apply an appropriate medical grade
surface disinfectant (e.g. Cavicide) to all surfaces of the paddle using a lint-free wipe per the
disinfectant’s instructions.
Store the device in the box if it is not to be used for an extended period of time.
Disassembly is not required when cleaning the handpiece and charging base.
NOTE: The Light Shields can also be autoclaved. DO NOT autoclave the
handpiece, battery pack, charging base or PinkWave™ Paddle.
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.
CAUTION: 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.
8

InfectionControlMeasures
RoutineMaintenance
Periodically check the lens for cured dental resins. If necessary, carefully remove any
adhered resin using a non-diamond dental hand instrument.The barrier sleeve helps keep
dental materials from adhering to the surface of the lens.
TROUBLESHOOTINGGUIDE
If the suggested solutions do not rectify the problem, please callVista Apex
at 877-273-9123 (Toll Free).
PROBLEM POSSIBLESOLUTION
Light will
notturn on 1. Check the unit’s indication light. If red, place the handpiece on
the charging base.
2. Remove the battery pack and inspect for any defects if none are found
reconnect the battery pack. A beep should be heard when the battery pack
is inserted.
Light is
not curing
properly
1. Verify the unit provides adequate optical power using a radiometer.
2. Verify that the appropriate curing mode is selected.
3. With the handpiece turned o, and the battery pack removed,
inspect the lens for residual cured composites/resins.
4. Check expiration date of composite/resin.
Batteries
will not
charge
1. Remove the battery pack and inspect for any defects, if none are found
reconnect the battery pack.
2. Make sure the battery pack is properly connected to the handpiece.
3. Make sure the charger is plugged in and verify the outlet is receiving power.
4. Lights on charger should pulsate.
CAUTION: To prevent cross-contamination, adisposable plasticsleevemust
be usedover thePinkWave™witheachuse.A low-density polyethylene plastic
disposable barriercoverstheentireunitand provides ahermeticallysealed
barrierbetweenthe handpieceandpatients.Thedisposablebarrierlimitspatient-
to-patientcontamination.Discardusedbarriersleevesaftereachpatient.
9

TECHNICALDATA
TECHNICAL
INFORMATION PINKWAVE™CORDLESSLEDCURINGLIGHT
Wavelength Range PinkWave™ optical power falls between 375-900nm (see graph below).
Irradiance Standard: > 1515 mW/cm2,Ramp: > 1515 mW/cm2,Boost: > 1720 mW/cm2,
Charger Input: 100-240 VAC, 50-60 Hz Nominal Consumption: 6W max
Manufacturer: Inter-Med, Inc. Model: PinkWave™
Dimensions without adapter (DxH):
87mm x 58mm Mass: 175g
Classication: Protection class II,
Handpiece Battery: 3.7 V nominal, 950mAh Li-ion
Battery Pack Manufacturer: HIBATT Battery Pack Model: IMR14650
Dimensions (LxD): 230mm x 20mm Mass: 88g
Classication: Type BF,
Intermittent Operation: The device has been designed solely for short-term operation.
Typical operating time at room temperature (23°C): 3-20 sec (depending on mode) per layer
of composite.
OperatingTime: Approximately 60 20-second cures.
Operating Conditions Time to Charge Empty Battery Pack: Approximately 3 hours
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
10

SYMBOLIDENTIFICATION
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 Regulations.
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 specied.
BATTERYPACKDISPOSAL
When disposing of electronic waste (ie. curing lights, charger, batteries and power
supplies), follow local waste and recycling guidelines. Batteries contain toxic material and
should not be disposed of in landlls or incinerators. Dispose of depleted batteries as
directed by your local solid waste handling regulations.
To dispose of the battery pack, we recommend www.call2recycle.com (for North America)
to locate a recycling facility near you.
11

SAFETYNOTES,
WARNINGSANDPRECAUTIONS
Read all instructions before operating this unit.The PinkWave™ LED Curing Light emits high
intensity light waves and must only be used as indicated in this manual.
SafetyNotes
The PinkWave™ Curing Lightis a medicaldevice whichis subject toIEC 60601-1 (EN60601-1)
and EMC directives IEC 60601-1-2 (EN60601-1-2) Edition 4.0, as well as the 93/42/EEC
Medical DeviceDirective.Thecuring lightcomplies with the relevantEU regulations.
The curing light 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 risks 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.
• Theuser should test thePinkWave™’soptical powerusing a radiometerprior to use.
• An irradiance value 800-1750 mW/cm2is acceptable for standard and ramp modes,
and a value 1350-3300 mW/cm2is acceptable for boost mode.
• The irradiance value should be measured at 10s within a 20s cycle for standard
and ramp modes.
• As with any heavily used medical device, the user needs to ensure a functional
backup is readily available.
• DO NOT look directly into the light output.The Autoclavable Light Shield should
always be used. Only Vista Apex provided Protective Eyewear or PinkWave™ Paddle
should be used.
• DO NOT expose soft oral tissues at close proximity. Maintain a safe distance
between the lens and the soft tissue.
• If using the PinkWave™ Curing Light in the Standard Mode and in close proximity
of the gingival tissue, DO NOT expose tissue for more than 20 seconds.
• In Boost Power Mode, DO NOT expose soft oral tissue for more than
9 seconds (3 cycles).
• DO NOT autoclave the handpiece, battery pack or charging base.
• 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 qualied and trained personnel only
in accordance with the instructions below.The manufacturer assumes no liability
for any damage arising from any other or improper use of this device.
12

• Use only the charger that is provided with the device, cable type for this device
is NEMA1-15 to IEC 320 C7 (non-polar).The use of any other charger can result
in damage to the battery pack.
• 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.
• There are no user-serviceable items in this handpiece or charger.
No modication of this equipment is allowed.
• In order to avoid electric shock, do not introduce any objects into the
device or remove the device enclosure.
• Shouldyou haveanyreason tosuspectthe safety of thedevice to becompromised,
the device must be taken out of operation and labeled accordinglyto prevent
third parties from inadvertently using a possibly defective device. Safety may be
compromised,e.g.,ifthe device malfunctions or is noticeably damaged.
• Keep solvants, 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.
• According to IEC 60601-1, this device must not be used in the presence of
ammable mixtures.
• Do not allow any cleaning agents to enter the device during cleaning as they
could cause an electrical short or a dangerous malfunction.
• Only Vista Apex may open the device housing and repair the device.
• UV emitted from this product. Eye or skin irritation may result from exposure.
Use appropriate shielding.
• IR emitted from this product. Do not stare at operating lamp.
• To avoid the risk of electric shock, this equipment must only be connected to
a supply mains with protective earth.
• 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. Other cables may negatively aect EMC
performance of the device.
• Use of this equipment adjacent to or stacked with other equipment should be
avoided because it could result in improper operation. If such use is necessary,
this equipment and the other equipment should be observed to verify that they
are operating normally.
13

• PinkWave™ must not be used in patients, or by users, with heart pacemaker
implants who have been advised to be cautious with regard to their exposure to
small electrical devices.
• This device has been tested and found to comply with relevant EMC regulations
and standards.These limits are designed to provide reasonable protection against
harmful interference in a typical medical installation.The device generates
radio frequency energy and, if not installed and used in accordance with these
instructions, may cause harmful interference to other devices in the vicinity.
However, there is no guarantee that interference will not occur in a particular
installation. If this device does cause harmful interference with other devices,
which can be determined by turning the device o and on, the user is encouraged
to try to correct the interference by one or more of the following measures:
• Reorient or relocate the receiving device.
Avoid stacking with other equipment.
• Increase the separation between the devices.
• Connect the device into an outlet on a circuit dierent
from that to which the other device(s) are connected.
• Consult the manufacturer for help.
• Portable RF communications equipment (including peripherals such as antenna
cables and external antennas) should be used no closer than 30 cm (12 inches)
to any part of the PinkWave™, including cables specied by the manufacturer.
Otherwise, degradation of the performance of this equipment could result.
OPERATING CONDITIONSAND
SAFETYCONSIDERATION
HeatGeneration
The metal parts of the PinkWave™ Curing Light do not overheat to the point of discomfort
or injury during standard operating durations (i.e. ve consecutive standard mode, ramp
mode or boost mode cures). However, care should be taken to allow the product to
completely cool to room temperature between patients (approximately two minutes),
to ensure overheating does not occur.
CAUTION: The PinkWave™ consists of high powered LEDs in the range
of 375 – 900nm.The device's intended use is within the oral cavity and
is to be used with the protective light shield.
14

SafetyEyewear
Please only useVista Apex supplied Protective Eyewear or PinkWave™ Paddle.
Anyone with a history of retinopathy should consult their eye specialist before operating
this unit. Use the PinkWave™ Curing Light extremely carefully and comply with all the
necessary safety precautions (including wearing suitable, light ltering safety glasses).
Anyone who has had a cataract operation may be especially sensitive to light and should
be advised against undergoing treatment with a PinkWave™ Curing Light unless adequate
safety precautions are taken such as wearing suitable, light ltering safety glasses.
AdverseReactions
There are no known adverse reactions.
Contraindications
Patients with a history of photosensitivity or photophobia or those using photosensitive
medications (such as antimalarial drugs, chlorpromazine, St. John’s wort, dimethyl-
chlorotetracycline and 8-methoxypsoralen) are contraindicated for PinkWave™ Curing
Light, and should not be exposed to the light emitting tip of the PinkWave™ Curing Light.
VISTAAPEXTERMSAND
CONDITIONSOFWARRANTY
The operator assumes all risk and liability for damages arising out of the improper use of
the PinkWave™ Curing Light. In the event of a defect in material or workmanship,Vista Apex
is limited, at its option, to replace of the defective product, a part thereof, or reimbursement
of the actual cost of the defective product. In order to take advantage of this limited
warranty, the defective product must be returned toVista Apex.
The PinkWave™ handpiece is warranted to be free from defects under normal usage
conditions for 3 years of its date of delivery; the batteries for 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
15

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.
RETURNPOLICY
30 days 15%
31+59 days 25%
60+ days Not Returnable
Vista Apex will accept for return previously purchased merchandise which is suitable
for resale or was shipped in error byVista 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 fromVista Apex.
Merchandise returned for credit must be received byVista Apex within 30 days of the
original invoice date.
ReturnStockPolicy
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 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 fromVista Apex will not be
restockable for credit.
16

• 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 toVista Apex
within 10 days of receipt of goods
APPENDIXELECTROMAGNETIC
COMPATIBILITY ANDSAFETYINFORMATION
The PinkWave™ Curing Light is tested according to IEC 60601-1-2, Edition 4.0.
Medical electrical devices are subject to particular preventive action and must be installed
and operated according to the EMC guidelines in the accompanying documents.
GuidanceandManufacturer'sDeclaration–ElectromagneticEmission
The following tables are guidelines according to the 4th edition of the medical
standard IEC 60601-1-2.
The PinkWave™ Curing Light is intended for use in the electromagnetic environment
specied below.The customer or the user of the PinkWave™ Curing Light should assure that
it is used in such an environment.
EMISSIONTEST COMPLIANCE ELECTROMAGNETICENVIRONMENTGUIDANCE
RF emissions CISPR 11 Group 1 PinkWave™ 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 PinkWave™ 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
GuidanceandManufacturer'sDeclaration–ElectromagneticImmunity
The PinkWave™ Curing Light is intended for use in the electromagnetic environment
specied below.The customer or the user of the PinkWave™ Curing Light should assure that
it is used in such an environment.
IMMUNITYTEST IEC 60601
TESTLEVEL COMPLIANCE
LEVEL ELECTROMAGNETICENVIRONMENTGUIDANCE
Electrostatic
discharge (ESD) IEC
61000-4-2 ± 8 kV contact
± 15 kV air ± 8 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%.
17

Electric fast transient
/burst IEC 61000-4-4
±2 kV forpower
supplylines
±1 kV forinput/
outputlines
±2 kV forpower
supplylines Mains powerquality shouldbethatof typical
commercialordental environment.
SurgeIEC
61000-4-5 ±1 kV linetoline
±2 kV linetoearth Mainspowerquality shouldbethatof typical
commercialordental environment.
Voltagedips,short
interruptionsand
voltagevariations
onpowersupply
inputline IEC
61000-4-11
0%UT;0.5cycleat0°, 45°,90°,
135°,180°,225°, 270° and315°
0%UT;1cycleand70% UT;25/30 cycles
Singlephase at 0°0%UT;250/300cycles
Mainspowerquality shouldbethatof typical
commercialordental environment.If theuserofthe
PinkWave™requirescontinuedoperationduring power
mainsinterruptions,it is recommendedthat
thePinkWave™be poweredfroman uninterruptible
powersupplyor battery.
Powerfrequency
(50/60Hz)magnetic
eldIEC 61000-4-8 30 A/m 30A/m Powerfrequencymagnetic elds shouldbeat
levelscharacteristic of atypicallocation in atypical
commercialordental environment.
Portableand mobile RFcommunicationsequipmentshould notbeusedcloser to anypartof PinkWave™,including cables,
thanthe recommended separationdistance calculatedfrom theequationapplicabletothe frequencyofthe transmitter.
ConductedRF
IEC61000-4-6 3V,6V 3Vrms,6V Portableandmobile RFcommunicationsequipment
shouldbe used noclosertoany part of thePinkWave™
CuringLight,including cables,than therecommended
separationdistancecalculatedfrom the equation
applicabletothe frequencyofthe transmitter.
Recommended separation distance
wherePis themaximumoutputpowerrating of the
transmitterinwatts (W)accordingto thetransmitter
manufacturerand distherecommendedseparation
distanceinmetres (m).Fieldstrengths fromxedRF
transmitters,asdeterminedby anelectromagneticsite
survey,shouldbeless thanthecompliancelevelin each
frequencyrange.D Interferencemayoccurin thevicinity
ofequipment marked withthefollowingsymbol:
RadiatedRF
IEC61000-4-3
3V/m
3Vfrom0.15 to
80MHz;
6Vfrom0.15 to
80MHzand
80%AM at 1kHz
3V/mfrom80MHz
to2.7GHz
3V/m
3Vfrom0.15 to
80MHz;
6Vfrom0.15 to
80MHzand
80%AM at 1kHz
3V/mfrom80MHz
to2.7GHz
Table:AccordingtoIEC60601-1-2,Edition4.0
NOTE: UTis thea.c.mains voltageprior toapplicationof thetest level.
NOTE: At80MHzand 800MHz,thehigher frequency rangeapplies.
NOTE: Theseguidelinesmay notapply inall situations.Electromagneticpropagationis
aectedbyabsorption andreection fromstructures,objectsand people.
a - Fieldstrengthsfromxedtransmitters,such asbase stationsforradio(cellular/cordless)
telephonesandland mobileradios,amateurradio,AMand FMradiobroadcast
andTVbroadcastcannot bepredictedtheoreticallywithaccuracy.Toassess the
electromagneticenvironmentduetoxedRF transmitters,anelectromagneticsite
survey shouldbe considered.
IMMUNITYTEST IEC 60601
TESTLEVEL COMPLIANCE
LEVEL ELECTROMAGNETICENVIRONMENTGUIDANCE
d = [ ] P
3.5
V1
d = [ ] P
12
V2
d = [ ] P
12
E1
d = [ ] P
23
E1
18

If the measured eld strength in the location in which the PinkWave™ is used exceeds
the applicable RF compliance level above, the PinkWave™ should be observed to verify
normal operation. If abnormal performance is observed, additional measures may be
necessary, such as reorienting or relocating the PinkWave™.
b- Over the frequency range 150 kHz to 80 MHz, eld strength should be less than 10 V/m.
RecommendedSeparationDistancesBetweenPortableandMobileRF
CommunicationsEquipmentandthe“PinkWave™CuringLight”
The PinkWave™ is intended for use in the electromagnetic environment in which radiated
RF disturbances are controlled.The customer or the user of the PinkWave™ can help
prevent electromagnetic interference by maintaining a minimum distance between
portable and mobile RF communications equipment (transmitters) and the PinkWave™
Curing Light as recommended below, according to the maximum output power of the
communication equipment. In general, portable RF communications equipment may
degrade performance if used closer than 30 cm (12 inches).
RecommendedSeparationDistancesBetweenPortable and
MobileRF CommunicationsEquipmentand the“PinkWave™CuringLight”
RatedMaximum
OutputPowerof
Transmitter(W)
SeparationDistanceAccordingToFrequencyofTransmitter(m)
150 kHz to 80 MHz
outside ISM bands 150 kHz to
80 MHz in ISM 80 MHz to
800 MHz 800 MHz
to 2.5 GHz
0.01 0.12 0.2 0.4 1
0.1 0.37 0.64 1.3 2.6
1 1.17 2 4 8
10 3.7 6.4 13 26
100 11.7 20 40 80
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
aected by absorption and reection from structures, objects and people.
d = [ ] P
3.5
V1
d = [ ] P
12
V2
d = [ ] P
12
E1
d = [ ] P
23
E1
19

1-877-418-4782
www.vistaapex.com
2200 South Street
Racine,WI53404
*Internal test data
available upon request
90734
Table of contents
Languages:
Other Vista Apex Dental Equipment manuals
Popular Dental Equipment manuals by other brands

Woodpecker
Woodpecker ULTRASURGERY Manual of use and maintenance

Horse Dental Equipment
Horse Dental Equipment HDE Evolution use instructions

TPC
TPC PC2635 Operational manual

KaVo
KaVo ARCTICA Engine Technician's Instructions

StarDental
StarDental DentalEZ 430 Series manual

erkodent
erkodent Erkopress 240 instructions