DenLite Illuminated
Dental Mirror
Directions for Use
DenLite Illuminated Dental Mirror
Miltex, Inc. assumes no responsibility for any injury to anyone, for any illegal or improper use of
the product that may result from failure to use this product in accordance with the instructions,
cautions, warnings, or statement of intended use published in this manual.
Miltex
® is a registered trademark of Miltex, Inc.
RAYOVAC® is a registered trademark of Rayovac Corporation.
Joy
® dish detergent is a registered trademark of Proctor and Gamble.
Citrace
CaviCide
Printed in USA
Contact Information
Miltex, Inc.
589 Davies Dr.
York, PA 17402 USA
Phone: 866-854-8300
Fax: 866-854-8400
Email: customerservice@miltex.com
Website: www.miltex.com
® is a registered trademark of Caltech Industries, Inc.
® is a registered trademark of Unimed Pharmaceuticals, Inc.
-Page 2 of 14-
Contents
Introduction.................................................................. .......4
Intended Use ................................................................... 4
Contraindications ............................................................. 4
Unpacking Checklist ........................................................ 4
Symbol Descriptions ........................................................ 4
Warnings .......................................................................... 5
Cautions ........................................................................... 5
Equipment Setup and Use .......................................... .......6
Charging the Batteries ..................................................... 6
Assembling the DenLite Illuminated Dental Mirror .......... 6
Using the DenLite Illuminated Dental Mirror .................... 7
Maintenance ............................................................... .......7
Handle Assembly ............................................................. 7
Battery Replacement ....................................................... 7
LED Light Cartridge ......................................................... 7
I-C
3 Battery Charger ........................................................ 8
Cleaning ........................................................................... 8
Disinfection....................................................................... 8
Sterilization ...................................................................... 8
Disposal ........................................................................... 9
Problem Solving .............................................................. 9
Specifications .................................................................. 9-10
Classification .................................................................... 10
Approvals.......................................................................... 10
Guidance and Manufacturer’s Declarations .................... 10-12
Replacement Parts .......................................................... 12
Miltex Warranty............................................................ .......13
Instruments and Products................................................. 13
Repairs ............................................................................. 13
Warranty Exceptions ........................................................ 13
1
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Introduction
This manual describes the setup and use of the DenLite Illuminated Dental Mirror, REF DP5000.
Intended Use
The DenLite Illuminated Dental Mirror is intended to provide additional illumination in a dental
cavity during dental examinations. Only trained dental clinical professionals should use this
device.
Contraindications
The LED DenLite light output is in a range that may cause premature polymerization of
composite materials.
Unpacking Checklist
Use the following checklist to verify the shipment contents. Please use the contact
information on page 2 if there are any items damaged or missing.
LED Light Cartridge
Autoclavable Handle Assemblies (quantity 3)
AAA I-C
I-C
Single-Use Mirror Heads (quantity 6)
• Directions For Use CD
• Instrument Tray
3 Rechargeable Batteries (quantity 4)
3 15-Minute Battery Charger
Symbol Descriptions
Dispose of Properly
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Warnings
A warning statement in this manual identifies a condition or practice which, if not corrected or
discontinued immediately, could lead to patient injury, illness, or death.
WARNING Do not re-use or sterilize the Single-Use mirrors.
WARNING The LED DenLite light output is in a range that may cause premature
polymerization of composite materials.
WARNING Do not look directly at an illuminated LED Light Cartridge. Temporary
blinding may result.
WARNING Do not use the I-C
WARNING To reduce risk of injury, charge only I-C
batteries. Other types of batteries may burst, causing personal injury and damage.
WARNING To reduce the risk of electric shock, unplug the charger from the outlet
before cleaning. Never immerse the charger in water or any other liquid. Do not
expose the charger to rain or snow.
WARNING Never disassemble the charger or alter the plug. This may cause electric
shock.
WARNING To reduce the risk of injury, charge only I-C
batteries. Other types of batteries may burst, causing personal injury or damage.
WARNING To reduce risk of battery explosion, follow the instructions and cautionary
markings on the battery charger, battery, and DenLite Illuminated dental Mirror.
WARNING The batteries may become warm during charging. Use caution when
handling.
WARNING The LED Light Cartridge may get hot during extended use. Allow the
instrument to cool before removing it.
3 Battery Charger in the patient area.
3, NiMH, and NiCd rechargeable
3, NiMH or NiCd rechargeable
WARNING Do not use the DenLite Illuminated Dental Mirror continuously for more
than 45 minutes.
Cautions
A caution statement in this manual identifies a condition or practice which, if not corrected or
discontinued immediately, could lead to equipment failure, equipment damage, or data loss.
Caution Never attempt to charge single-use alkaline or zinc carbon batteries in the
charger.
Caution Do not charge Rechargeable Alkaline (Renewal) batteries in the battery
charger.
Caution Do not immerse or soak the handle, collet assembly, LED light cartridge, or
batteries of the DenLite in any liquid.
Caution Do not autoclave the batteries or the LED Light Cartridge. Damage to the
batteries and LED Light Cartridge will occur.
-Page 5 of 14-
2
Equipment Setup and Use
Charging the Batteries
The battery charger will charge 2 I-C3 AAA batteries in 15 minutes. A fully charged set of new
batteries will last 45 minutes in the DenLite Illuminator Dental Mirror.
1. Place the battery into the charging pocket.
a. Push the positive (+) terminal of the battery against the sliding contact.
b. Press the negative (-) end of the battery to seat it securely into the charging pocket.
2. Flip the prongs from the back of the charger and plug the charger into a standard 110V wall
outlet. You will hear the cooling fan when the charger is operating.
3. A green LED light indicates the charging status and will turn off when charging is complete.
Upon completing the charge, unplug the charger and remove the batteries. It is safe to leave
the batteries into a plugged-in I-C
unplugged I-C3 battery charger
Assembling the DenLite Illuminated Dental
Mirror
3 battery charger. However, do not leave the batteries in an
-Page 6 of 14-
1. Place the batteries inside the handle base with the positive (+) terminal facing upward.
2. Insert the LED Light Cartridge into the handle base.
3. Screw the collet onto the handle base to the off position (first click).
4. Attach the collet ring (1 turn) onto the collet.
5. Insert the Single-use Mirror inside the collet ring and tighten.
Using the DenLite Illuminated Dental Mirror
1. Fully tighten the collet assembly and the LED Light Cartridge will illuminate.
2. Loosen the collet assembly to the detent position and the LED Light Cartridge will
extinguish.
3. Remove and properly dispose of the Single-Use Mirror after each use.
4. Sterilize the DenLite handle, collet and collet ring after each use, page 11. If the
DenLite instrument is dropped at anytime:
• Use a new handle assembly and a new mirror.
• Properly dispose of the dropped mirror.
• Re-sterilize the handle assembly.
Maintenance
Handle Assembly
Before each use, check the handle assembly for cracks and/or other imperfections.
Replace the handle assembly as necessary (part number DP5200).
Battery Replacement
If the lamp does not illuminate or is dim, replace the batteries.
1. Remove the collet assembly.
2. Remove the LED Light Cartridge.
3. Remove the batteries from the handle assembly and replace with fully charged
batteries. Only use I-C
4. Reassemble the DenLite Illuminated Dental Mirror, page 6.
In the USA, call 1-800-SAV-LEAD for instructions on how to recycle batteries. This device is
subject to EU Directive 2002/96/EC (WEEE). It is not registered for use in private households,
and may not be disposed of at municipal collection points for waste electrical and electronic
equipment. For users outside the United States, contact your local authorities on recycling
procedures.
3, NiMH, or NiCd as replacement battery types.
Dispose of Properly
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LED Light Cartridge
Caution The LED Light Cartridge may get hot during extended use. Allow the
LED Light Cartridge to cool before removing it.
If the LED Light Cartridge no longer illuminates and you have replaced the batteries,
discontinue use and replace the LED Light Cartridge.
1. Remove the collet assembly.
2. Remove the LED Light Cartridge and replace with a new LED Light Cartridge (part
number DP5150).
3. Reassemble the DenLite Illuminated Dental Mirror, page 6.
I-C3 Battery Charger
WARNING To reduce the risk of injury, charge only I-C3, NiMH or NiCd rechargeable
batteries. Other battery types may burst, causing personal injury or damage.
Do not leave batteries in an unplugged charger.
Cleaning
WARNING Do not re-use or sterilize the Single-Use mirrors.
Caution Do not immerse or soak the handle, collet assembly, LED light cartridge, or
batteries of the DenLite in any liquid.
You can wipe the handle, and collet assembly with cold steriliants and disinfectants.
You can wipe the LED Light Cartridge clean with a cotton swab and warm water.
You can wipe the surface of the I-C
3 Battery Charger with a damp cloth.
Disinfection
WARNING Do not re-use or sterilize the Single-Use mirrors.
Caution Do not immerse or soak the handle, collet assembly, LED light cartridge, or
batteries of the DenLite in any liquid.
Use the following solutions to disinfect the DenLite handle and collet assembly.
• Dual synergized quatennary solution (17.2% isopropanol, 0.28% Di
isobutylphenoxyethoxyethyl, dimethyl benzyl ammonium chloride) such as CaviCide
brand surface disinfectant
• O-phenylphenol solution (0.12%) such as Citrace
• Isopropanol Alcohol 70%
® brand hospital germicidal deodorizer
®
-Page 8 of 14-
• Mild soap and water solution such as Joy® soap and water solution
Sterilization
WARNING Do not re-use or sterilize the Single-Use mirrors.
Caution Do not immerse or soak the handle, collet assembly, LED light cartridge, or
batteries of the DenLite Illuminated Dental Mirror in any liquid.
Do not autoclave the LED Light Cartridge or batteries.
The handle and collet assembly are the only steam autoclavable parts (249.8° F / 121° C for
15 minutes).
Disposal
Handle Assembly
Single-Use Mirror
Batteries
Perform a final sterilization and throw the handle assembly into the trash.
The mirror is considered medical waste. Dispose of in accordance with
local, state, and federal regulations.
In the USA, call 1-800-SAV-LEAD for instructions on how to recycle
batteries. For users outside the United States, contact your local
authorities on recycling procedures or go to http://www.rbrc.org/ for
recycling information. In Canada, please go to
http://www.rawmaterials.com/rmcmain.htm
Problem Solving
Problem Cause Solution
There is low light output
or no light output.
Mirror doesn’t slide into
the collet cap.
The batteries are inserted in
the handle incorrectly.
The batteries are not
charged.
The LED Light Cartridge is
defective.
The mirror is not fully
inserted into the collet
The collet cap is screwed
too tightly on the collet.
.
Dispose of Properly
Disassemble the light handle,
insert the batteries with the
positive (+) nubbin facing upward,
and reassemble the light handle,
page 5.
Follow charging instructions, page
5.
Remove the collet cap and the
collet. Replace the LED Light
Cartridge and reassemble.
Loosen the collet ring and then
firmly push the mirror out of the
collet. Retighten the collet ring.
Loosen the collet ring and then
firmly push the mirror into the
collet. Retighten the collet ring.
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The charger green light
does not turn on or it
flashes.
Specifications
The batteries are not loaded
properly.
Charging is complete. Remove the batteries from the IThe batteries are damaged. Discontinue use of these batteries.
The charger is outside of its
operating temperature.
Reload the batteries (page 5) and
firmly press each battery down to
the bottom of the charging pocket.
3 Battery Charger and use.
C
Allow the charger to adjust to
room temperature and re-start the
charging process.
Length
Max Diameter
Weight
Operating
Conditions
Storage
Conditions
Performance
Electrical
7.25” (18.4 cm) (without mirror and in the off/detent position)
0.875” (2.2 cm)
2.50 oz (71.1 grams) (without mirror)
60° F to 77° F
16° C to 25° C
900 hPa to 1060 hPa
50 to 95% RH
-4° F at 50% RH to 120° F at 95% RH
-20° C at 50% RH to 50° C at 95% RH
500 hPa to 1060 hPa
45 minutes nominal On
1.2 V NiMh batteries (qty 2 AAA)
Maximum Rating 800 mAh
Classification
Type of protection against electric shock
Degree of protection against electric shock
Degree of protection against ingress of water
Degree of safety of application in the presence of a
flammable anesthetic mixture with air, oxygen, nitrous oxide
Mode of Operation
LED Product
Internally Powered Device @ 2 x
1.2V dc 800 mA hr maximum
Type BF
IPX3
Device not suitable for use in
flammable environment.
Continuous
Class 1
Approvals
CERTIFIED TO: CAN/CSA C22.2 No. 601.1-M90,
including amendments 1 and 2; EN/IEC 60825-1; UL
60601-1
The CE mark on this product indicates that it has been
tested to and conforms with the provisions noted within
the 93/42/EEC Medical Device Directive.
EN60601-1-2:2001
EN60601-1:1990
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Authorized European Representative Address:
E.U. Representative
Miltex GmbH
78604 Rietheim-Weilheim/Germany
CB Scheme Certificate
IEC 6060-1-1
Guidance and Manufacturer’s Declarations
Emissions for all EQUIPMENT and SYSTEMS
The REF DP5000 DenLite Illuminated Dental Mirror is intended for use in the electromagnetic
environment specified below. The customer or user of the DP5000 DenLite Illuminated Dental Mirror
should assure that it is used in such an environment.
Emissions Test Compliance Electromagnetic Environment - Guidance
RF Emissions
CISPR 11
RF Emissions
CISPR 11
Harmonics
IEC 61000-3-2
Flicker
IEC 61000-3-3
The REF DP5000 DenLite Illuminated Dental Mirror is intended for use in the electromagnetic
environment specified below. The customer or user of the REF DP5000 DenLite Illuminated Dental
Mirror should assure that it is used in such an environment.
Immunity Test IEC 60601 Test
ESD
IEC 61000-4-2
EFT
IEC 61000-4-4
Surge
IEC 61000-4-5
Voltage Dips,
short interruptions,
and voltage
variations on
power supply input
lines.
IEC 61000-4-11
Power Frequency
50/60Hz
Magnetic Field
IEC 61000-4-8
Group 1 The DP5000 DenLite Illuminated Dental Mirror uses RF en ergy only
for its internal function. Therefore, its RF emissions are very low
and are not likely to cause any interference in nearby el ectronic
equipment.
Class B
N/A
N/A
Immunity for all EQUIPMENT and SYSTEMS
Level
± 6kV Contact
± 8kV Air
±2kV Mains
±1kV I/O
±1kV Differential
±2kV Common
>95% Dip in 0.5
Cycle
60% Dip in 5
Cycles
30% Dip for 25
Cycles
>95% Dip in 5
Seconds
3 A/m N/A Power frequency magnetic fields
The DP5000 DenLite Illuminated Dental Mirror are suitable for use
in all establishments other than domestic, and those directly
connected to the public low-voltage power supply network that
supplies buildings used for domestic purposes.
Compliance
Level
± 6kV Contact
± 8kV Air
N/A Mains power quality should be that
N/A Mains power quality should be that
N/A Mains power quality should be that
Electromagnetic Environment Guidance
Floors should be wood, concrete, or
ceramic tile. If floors are synthetic
material, the relative humidity should
be at least 30%.
of a typical commercial or hospital
environment.
of a typical commercial or hospital
environment.
of a typical commercial or hospital
environment. If the user of the REF
DP5000 DenLite Illuminated Dental
Mirror requires continued operation
during power mains interruptions, it
is recommended that the REF
DP5000 DenLite Illuminated Dental
Mirror be powered from an
uninterruptible power supply or
battery.
should be at levels characteristic of a
typical location in a typical
commercial or hospital environment.
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Guidance and Manufacturer’s Declaration - Emissions
The REF DP5000 DenLite Illuminated Dental Mirror is intended for use in the electromagnetic
environment specified below. The customer or user of the REF DP5000 DenLite Illuminated Dental
Mirror should assure that it is used in such an environment.
Immunity
Test
Conducted
RF
IEC 61000-46
Radiated RF
IEC 61000-43
IEC 60601
Test Level
3 Vrms
150 kHz to
80MHz
(outside ISM
bands)
3 V/m
80 MHz to 2.5
GHz
Compliance
Level
N/A
3 V/m
Electromagnetic Environment - Guidance
Portable and mobile RF communications
equipment should be used no closer to any
part of the REF DP5000 DenLite Illuminated
Dental Mirror, including cables, than the
recommended separation distances
calculated/listed below:
d= (1.17)√ P
d = (1.17)√ P
80 to 800 MHz
d= (2.33)√ 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 fixed RF transmitters, as
determined by an electromagnetic site survey,
should be less than the compliance level in
each frequency range.
Interference may occur in the vicinity of
equipment marked with the following symbol:
Recommended Separations Distances between portable an d mobile RF Communications
equipment and the REF DP5000 Dental Illuminated Mirror Handle
The REF DP5000 Dental Illuminated Mirror Handle is intended for use in the electromagnetic
environment in which radiated disturbances are controlled. The customer or user of the REF DP5000
Dental Illuminated Mirror Handle can help prevent electromagnetic interference by maintaining a
minimum distance between portable and mobile RF Communications Equipment (transmitters) and the
REF DP5000 Dental Illuminated Mirror Handle as recommended below, according to the maximum
output power of the communications equipment.
Max Output
Power
(watts)
0.01
0.1
1
10
100
Separation (m)
150kHz to 80MHz
d 1.1= ( 7)√P
N/A 0.117 0.233
N/A 0.37 0.74
N/A 1.17 2.33
N/A 3.70 7.37
N/A 11.70 23.30
Separation (m) 80 to
800MHz
d= (1.17)√P
Separation (m) 800MHz to
2.5GHz
d= (2.33)√P
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Replacement Parts
DP5000
Complete DenLite Illuminated Dental Mirror Kit
DP5070
DP5200
DP5410
DP5030
DP5150
DP5400
DP5005
Illuminator Tip
DenLite Handle Assemblies (quantity 1)
AAA I-C
Single-Use Mirror Heads (box of 50)
LED Light Cartridge
DenLite AAA Battery Charger Set
Quick Reference Card / Directions for Use CD
Miltex Warranty
3 Batteries (quantity 4)
Instruments and Products
Miltex hereby warrants all Miltex product purchased directly from Miltex or an Authorized
Dealer in accordance with the following terms and conditions:
All Miltex instruments and products are guaranteed to be free from defects in material and
workmanship when used for their intended surgical or dental purpose. Any Miltex product that
proves defective in workmanship or material will either be repaired or replaced, at Miltex’s
discretion, without charge. Products not purchased from an authorized source may not be
authentic or meet Miltex’s quality standards and may have been tampered with.
Other Instrument and Product Warranties:
• DenLite – 90 days
• Union Broach Chiropractic Mallet – 90 days
• Union Broach Electrical Devices – 1 year except for Sprint TCM – 2 years
• Cassettes – 4-year warranty on all moving parts and lifetime guarantee against
corrosion
-Page 13 of 14-
Repairs
Instruments and products repaired by the Miltex Instrument Repair Service are guaranteed to
be free from defects in material and workmanship for 90 days when used for the ir intended
surgical or dental purpose. Any Miltex repair that proves defective in workmanship or material
within this 90-day period will either be repaired again or replaced, at Miltex’s discretion, without charge. Instruments bust be cleaned and sterilized prior to returning to Miltex for repair.
Warranty Exceptions
This warranty is void for Miltex instruments and products serviced by any person or facility
other than the Miltex Instrument Repair Services. Any custom made, custom etched or
neutralized products are not returnable. Warranties are not valid for Miltex instruments and
products that prove defective as a result of improper care and cleaning or misuse.
Instruments or products that are damaged I fire, flood or other acts or disasters are also
excluded from warranty. Except as set forth in these Terms and Conditions, Miltex makes no
other representations and warranties regarding its instruments or products, either expressed
or implied. In addition, in no event will Miltex be liable for any incidental, special or exemplary
damages or loss of profits in connection with the use of Miltex instruments and products.
Miltex, Inc.
589 Davies Dr.
York, PA 17402 USA
Phone (866) 854-8300
Email customerservice@miltex.com
Internet www.miltex.com
-Page 14 of 14-
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