Vista Apex PinkWave User manual

Inter-Med, Inc.
2200 South St.
Racine, WI 53404, USA
Tel:[phone]
Rx ONLY
91037-I-AP-ENG(5)
User’s Manual
For use by qualied professionals only.
This manual must be read thoroughly and
understood prior to using the PinkWave™ Curing Light.
90734
VISTA | APEX

2
TABLE OF CONTENTS
Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3
Welcome to PinkWave™ . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3
Contents of the PinkWave™ Kit . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .. . . . . . . . . . . . . . . . . . . . . . . .. . 3
Intended Use / Indications for Use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3
PinkWave™ Set-Up and Use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4
Unpacking the Container . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4
Introduction to the PinkWave™ . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4
Attaching the Battery Pack to the Handpiece . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5
Attaching and Removing the Curing Light Shield . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5
Charging the Battery Pack . . . . . . . . . . . . . . . . . . . . . .. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6
PinkWave™ Operation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7
Curing Modes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7
Quick Curing Guide . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7
Transillumination Mode . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7
Disinfection / Sterilization . . . . . .. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7
Infection Control Measures . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8
Routine Maintenance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .. . . . . . . . . . . . . . . . 8
Troubleshooting Guide . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9
Technical Data . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10
Symbol Identication . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11
Battery Pack Disposal . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11
Safety Notes, Warnings and Precautions . . . . . . . . . . . . . . . . . .. . . . . . . . . . . . . . . . . . . . . . . . . . 11-14
Operating Conditions and Safety Consideration . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ..14
Heat generation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14
Safety Eyewear . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14
Vista Apex Terms and Conditions of Warranty . . . . . . . . . . . . . . . . . . . . . .. . . . . . . . . . . . . . . . . . . . 15
Return Policy . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16
Appendix – Electromagnetic Compatibility . . . . . . . . . . . . . . . . .. . . . . . . . . . . . . . . . . . . . . . . . . 16-19
and Electrical Safety Information

3
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 PinkWave™
Congratulations on your decision to incorporate the PinkWave™ curing light into your
practice. Vista Apex's PinkWave™ curing light uses multiple wavelengths (395 – 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 eective.
vistaapex.com 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 Pink-
Wave™, please call our customer service department at 877.418.4782
(Toll Free).
Contents of the PinkWave™ Kit
The PinkWave™ Curing Light Kit is composed of the following:
(1) Cordless handpiece
(1) Charging base
(100) Disposable barrier sleeves
(1) Instructions for Use
(5) Autoclavable light shields
(1) Charging cord
(1) Battery pack
(3) Protective Eyewear
NOTE: All components are non-sterile
Intended Use / Indications for Use
Source of illumination for curing photo-activated dental restorative materials and adhesives.

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PinkWave™ Set-Up and Use
Unpacking the Container
No special assistance is required to unpack and assemble the PinkWave™.
If you have questions or concerns, please visit 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 Dental Products at 877.418.4782 (Toll Free) as well as the delivery service to le a
complaint.
Introduction to the PinkWave™
Please reference the image below to familiarize yourself with the PinkWave™.
ON/OFF Button
Mode
Indicators
ON/OFF Button
Battery Pack
Curing Light
Anti-Rotation Pins
Mode
Button Battery
Indicator

Attaching/Detaching the Battery Pack to the Handpiece
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! Do NOT try to screw the battery pack into the handpiece in the wrong
orientation. The battery pack should be easy to insert.
Attaching and Removing the Barrier Sleeve
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:Barrier sleeves are for single use only.
NOTE: Only PinkWave™ Curing Light Barrier sleeves should be
used on the PinkWave™ Curing Light.
5
Using the Autoclavable Light Shields
NOTE: DO NOT operate PinkWave™ without the light shield
or protective eyewear.
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

Charging the Battery Pack
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.
6
Pulsating
Pink Light
CHARGING
Solid
Pink Light
FULLY
CHARGED

PinkWave™ Operation
Selecting your curing mode
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.
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.
Transillumination Mode
The transillumination mode can be executed by toggling through modes until all lights are il-
luminated and pressing the ON/OFF button. The transillumination light is turned o the same
way, by pressing and holding down the ON/OFF button.
NOTE: Setting is memorized as default until changed
3 B 3-second Boost Mode
20 R 20-second Ramp Mode
20 S 20-second Standard Mode
All Transillumintor
3B 20R 20S Transillumintor Mode selected
7
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

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 the PinkWave Curing Light, Protective Eyewear and Light Shields with an approved
surface disinfectant solution such as a quaternary ammonium compound product that
contains 20% alcohol or less. Wipe, do not spray, solution and follow the manufacturer’s
cleaning recommendations. Prevent liquids from entering openings on the unit.
Note: The Light Shields can also be autoclaved. If you choose to autoclave The Light Shields,
they should be autoclaved at 132˚C for 4 minutes. DO NOT autoclave the handpiece, battery
pack, or charging base
DO NOT AUTOCLAVE PINKWAVE UNIT, BATTERY PACK OR CHARGING
BASE.
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.
• Disassembly is not required when cleaning the handpiece and charging base.
Infection Control Measures
CAUTION:
To prevent cross-contamination, a disposable plastic sleeve must be used over the
PinkWave™ with each use. A low-density polyethylene plastic disposable barrier
covers the entire unit and provides a hermetically sealed barrier between the hand
piece and patients. The disposable barrier limits patient-to-patient contamination.
Discard used barrier sleeves after each patient.
Routine Maintenance
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.
8

Technical
Information
PinkWave™ Cordless LED Curing Light
Wavelength Range PinkWave™ optical power falls between 395-900nm (see graph below).
9
Problem Possible Solution
Light will not turn 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 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
Troubleshooting Guide
If the suggested solutions do not rectify the problem, please call Vista Apex 877.418.4782
(Toll Free).
Technical Data,

10
Technical Data, continued
Technical
Information
PinkWave™ Cordless LED Curing Light
Irradiance
Charger
Standard: >1515mW/cm2, Ramp: >1515mW/cm2, Boost: >1720mW/cm2
Input: 100-240 VAC, 50-60 Hz
Nominal Consumption: 6W max
Manufacturer: Inter-Med, Inc.
Model: PinkWave™
Dimensions without adaptor (DxH): 87mm x 58mm
Mass: 175g
Classication: Protection class II,
Handpiece Battery Pack: 3.7 V nominal, 950mAh Li-ion
Battery Manufacturer: HIBATT
Dimensions (LxD): 230mm x 20mm, Battery Model: IMR 14650
Mass: 88g
Classication: 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.
Operating Time:
Approximately 1 hr fully charged. Approximately 60 20 second cures.
Operating
Conditions
Time to Charge Emply Battery Pack: Approx. 3 hrs.
Temperature: 10°C - 40°C (59°F - 104° F)
Atmospheric Pressure: 697hPa-1013hPa
Transport and
Storage Conditions
Temperature: -20°C - 40°C (-4°F - 104° F)
Relative Humidity: 30%-90% (non-condensing)
Atmosperic Pressure: 500hPa-1400hPa
10C
40C
1013hPa
697hPa
-20C
40C
90 (max)
30%
1400 bPa
500hPa

11
Battery Pack Disposal
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 landlls 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.
Safety Notes, Warnings and Precautions
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.
Symbol Identication
Description for additional symbols.
Serial Number Follow instructions
for use
Manufacturer Temperature
Limitation
Manufacturer Date Humidity Limitation
Protected Class II
Electrical Insulation Atmospheric Pressure Limitation
Type BF
Applied Part Batch Code/ Lot number
Keep dry Prescription
Part Number Warning/Caution
Do Not Dispose Of Autoclavable
Rx ONLY
Single use
132

12
Safety Notes
The PinkWave™ Curing Light 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 curing light complies with the relevant EU 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 equip-
ment 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.
• The user should test the PinkWave™’s optical power using a radiometer prior to use.
• An irradiance value 800-1750mW/cm is acceptable for standard and ramp modes,
and a value1350-3300mW/cm is 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 and/or protective
eyewear should always be used. Only Vista Apex provided safety glasses 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 insert ngers, instruments, or other objects into the rear of the handpiece
when the battery pack is removed
• DO NOT autoclave the handpiece, battery pack, charging base.
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 instructions below. The manufacturer assumes no liability for
any damage arising from any other or improper use of this device.

13
CAUTION
• 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 the handpiece or charger. No modication
of this equipment is allowed.
• 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.
• 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.
WARNING
•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 aect EMC performance
of the device

14
• 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
• 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 dierent 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 specied by the
manufacturer. Otherwise, degradation of the performance of this equipment could
result
Operating Conditions and Safety Consideration
Heat generation
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
395 – 900nm. The device’s intended use is within the oral cavity and is to be used
with the protective light shield.

15
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.
Adverse Reactions
There are no known adverse reactions.
Contraindications
• The PinkWave™ Curing Light is contraindicated in patients with a known history of
hypersensitivity or allergy to any of the ingredients or their analogs.
• Patients with a history of photosensitivity or photophobia or those using photosensitive
medications (such as antimalarial drugs, chlorpromazine, St. John's wort,
dimethylchlorotetracycline and 8-methoxypsoralen) are contraindicated for PinkWave™
Curing Light screening and should not be exposed to the light emitting tip of the PinkWave™
Curing Light.
Vista Apex Terms and Conditions of Warranty
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 to Vista 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 dis-
tributors 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 autho-
rized 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.

16
Appendix – Electromagnetic Compatibility and Safety
Information
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 opertated 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.
The PinkWave™ Curing Light is intended for use in the electromagnetic environment
specied below. The customer or the user of the PinkWave™ Curing Light should assure that it
is used in such an environment.
Emission test Compliance Electromagnetic
enviroment-guidance
RF emissions CISPR 11 Group 1 PinkWave™ uses RF energy only for it interna function.
Therefore, its RF emissions are very low and are not likely
to cause any interference in nearby electronic equipment.
RF emissions CISPR 11 Class B PinkWave™ is suitable for use in all establishments, includ-
ing domestic establishments and those directly connect-
ed 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/ick-
er emissions IEC 61000-3-3
Complies N/A
Table according to IEC 60601-1-2, Edition 4.0.

17
Guidance and Manufacturer‘s Declaration
– Electromagnetic Immunity
The PinkWave™ Curing Light is intended for use in the electromagnetic environment specied
below. The customer or the user of the PinkWave™ Curing Light should assure that it is used in
such an environment.
Power frequency
(50/60Hz)
magnetic eld IEC
61000-4-8
30 A/ m 30 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
PinkWave™, including cables, than the recommended separation distance calculated from the
equation applicable to the frequency of the transmitter.
Immunity test IEC 60601 test level Compliance
level
Electromagnetic
environment-guidance
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%
Electric Fast
transient/burst IEC
61000-4-4
± 2kV for power
supply lines
± 1kV for input/out-
put lines
±2kv for
power
supply lines
Mains power quality should be that of
typical commercial or dental environment
Surge IEC
61000-4-5
± 1kV line(s) to line(s)
± 2kV line(s) to earth
Mains power quality should be that of
typical commercial or dental environment.
Voltage dips, short
interruptions and
voltage variations
on power supply
input lines IEC
61000-4-11
0% UT; 0.5cycle at 0°, 45°, 90°,
135°,180°, 225°, 270° and 315°
0% UT; 1cycle and 70% UT; 25/30
cycles
Single phase at 0° 0% UT; 250/300
cycle
Mains power quality should be that of
typical commercial or dental environment.
If the user of the PinkWave™ requires
continued operation during power mains
interruptions, it is recommended that
the PinkWave be powered from an
uninterruptible power supply or battery.

18
Immunity
test
IEC 60601 test
level
Compliance level Electromagnetic
enviroment-guidance
Conducted RF
IEC 61000-4-6

Radiated RF
IEC 61000-4-3
3V, 6V


3V/m


3V from 0.15 to
80MHz;
6V from 0.15 to
80MHz and 80%
AM
at 1kHz

3V/m from 80MHz
to 2.7GHz
3Vrms, 6V


3V/m


3V from 0.15 to
80MHz;
6V from 0.15 to
80MHz and 80%
AM
at 1kHz

3V/m from 80MHz
to 2.7GHz
Portable and mobile RF communications
equipment should be used no closer to any
part of the PinkWave Curing Light, including
cables, than the recommended separation dis-
tance calculated from the equation applicable
to the frequency of the transmitter.
Recommended separation distance
where P is the maximum output power rating
of the transmitter in watts (W) according to
the transmitter manufacturer and d is the rec-
ommended separation distance in metres (m).
Field strengths from xed RF transmitters, as
determined by an electromagnetic site survey,
should be less than the compliance level in
each frequency range. D 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 2: 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
broad-cast 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 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.

19
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 4: These guidelines may not apply in all situations. Electromagnetic propagation is
aected by absorption and reection from structures, objects and people.
Recommended Separation Distances Between Portable and Mobile RF communications
equipment and the “PinkWave™ Curing Light”
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).
Table: According to IEC 60601-1-2, Edition 4.0
Recommended separation distances between portable and mobile RF communications
equipment and the PinkWave Curing Light
Rated maximum output
power of transmitter W
Separation distance according to frequency of transmitter 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

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1-877-418-4782
www.vistaapex.com
*Internal test data
available upon request
90734