OBTURA SPARTAN Obtura III MAX User manual

© 2019 Obtura Spartan®

OPERATOR’S MANUAL HEATED GUTTA PERCHA SYSTEM
Page 2
TABLE OF CONTENTS
Warranty ............................................................................................................................................................................................................................. 2
Safety Information ............................................................................................................................................................................................................. 2
Overview ............................................................................................................................................................................................................................ 3
Quick Start Guide .............................................................................................................................................................................................................. 4
Heated Gutta Percha System ............................................................................................................................................................................................ 4
System Description ........................................................................................................................................................................................................... 5
Unpacking and Assembling .............................................................................................................................................................................................. 5
Operation ....................................................................................................................................................................................................................... 5-6
Installing a Needle ............................................................................................................................................................................................................. 6
Bending the Needle ........................................................................................................................................................................................................... 6
Loading Gutta Percha ........................................................................................................................................................................................................ 6
Expressing Gutta Percha .................................................................................................................................................................................................. 7
Sterilization Instructions .................................................................................................................................................................................................... 7
Maintenance ................................................................................................................................................................................................................... 7-8
Extended Maintenance ...................................................................................................................................................................................................... 8
Handpiece Bushing ........................................................................................................................................................................................................... 8
Plunger Shaft Assembly .................................................................................................................................................................................................... 9
Plunger Seal Assembly...................................................................................................................................................................................................... 9
Needle Nut ......................................................................................................................................................................................................................... 9
Handpiece Cable Assembly/Error Codes ......................................................................................................................................................................... 9
Handpiece Attachment/Detachment .............................................................................................................................................................................. 10
Theory of Operation ......................................................................................................................................................................................................... 10
Frequently Asked Questions ........................................................................................................................................................................................... 10
Theory of Operation ......................................................................................................................................................................................................... 10
Factory Repair/Contact Us .............................................................................................................................................................................................. 11
Replacement Parts .......................................................................................................................................................................................................... 11
EMC Table ........................................................................................................................................................................................................................ 12
Guidance & Manufacturer’s Declaration Electromagnetic Immunity Tables ............................................................................................................. 12-13
Recommended separation distances between portable and mobile RF communications equipment
and the Obtura III Max Heated Gutta Percha System .................................................................................................................................................... 14
Description of Symbols ................................................................................................................................................................................................... 15
Safety Data Sheet........................................................................................................................................................................................................ 16-22
TWO-YEAR WARRANTY
Young Innovations, Inc. warrants that all products sold by the company are of high quality materials and workmanship. The Obtura III MAX is warranted
against defects in materials and workmanship for two (2) years from date of purchase. Young Innovations, Inc. liability and customer’s sole remedy in
the event of any claimed defect shall be limited to repair or replacement of the item at Obtura Spartan’s option. All parts or components are warranted
for two (2) full years, excluding consumable items such as plunger seals, needles and cleaning accessories. This warranty does not cover damage
caused by misuse or abuse of the item.
All consequential damages are excluded. This warranty is given in lieu of any other warranties, expressed or implied, including any warranty of
manufacturability or tness for use. Failure to clean the instrument according to the instructions in this manual may void the warranty
To obtain warranty service, the customer must return the instrument (shipping charges pre-paid) to the factory or an authorized service center with a
written explanation of the claim. To obtain warranty service, the instrument must be received within 2 years from date of purchase.
To register for your Obtura III MAX two-year warranty, please take a moment to ll out the registration card included in your clear plastic
introductory packet.

OPERATOR’S MANUAL HEATED GUTTA PERCHA SYSTEM
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SAFETY INFORMATION
1. Please read the operator’s manual in its entirety before using the Obtura III MAX.
2. To avoid explosion hazard, do not use the Obtura Ill MAX in the presence of ammable materials.
3. Do not allow heated parts to come in contact with soft tissue. All handpiece components attached to the heating chamber are hot and may
cause burns if used improperly. During normal use, the handpiece is not intended to contact the patient. Always use a thermal protector for
added protection in the event of accidental patient contact. In addition, the use of a rubber dam will increase protection.
4. Do not abuse the handpiece cable. Ensure that the handpiece cable and power supply cable are free from cuts, nicks or other damages.
5. Place the main control unit within sufcient proximity to the patient so as not to disrupt operation by reaching too far with the handpiece.
6. This Obtura System complies with current Electromagnetic Compatibility standards (IEC 60601-1-2). However, the user should ensure that any
possible electromagnetic interference does not present an additional risk of interfering with or damaging the device or any other electronic
devices in the vicinity (see pages 12-15).
7. The Obtura System does not use RF energy to function. Therefore, it is not likely to cause any interference in nearby electronic equipment.
(see pages 12-15).
8. The Obtura System should only be used with the provided cables and accessories. Use of other cables or accessories has the potential to
damage the device or affect compliance to EMC standards.
9. Cables and Accessories:
• Handpiece Cord - max length 8’, IEC 60601-1
• Power Cord - max length 8’, IEC 60601-1
10. Requirements of cables and accessories:
• 2-wires unshielded cable - 1.5m, AC/DC Adapter Type: FW7555M/12
• Obtura Handpiece shielded cable - 2m, Handpiece Attachment/Detachment
Disclaimer: Young Innovations, Inc. does not assume any responsibility or liability for incorrect diagnosis or Jailed procedures due to operator error or equipment malfunction.
Clinicians who are not familiar with the techniques or intended uses of this product should attend courses and receive training on the subject prior to use.
To ensure continued compliance with EC Directives and safety, use only the power supply included with this product or supplied by
Young Innovations, Inc., part number 823-711.
OVERVIEW
Congratulations on your purchase of the Obtura III Max! Please read the entire manual prior to using this unit. Here are some useful tips that
will aid your usage of the Obtura III Max:
When you are ready to practice with your Obtura III MAX, you should become familiar with its components. After attaching the needle and thermal
protector, turn the Obtura III MAX ON and set it to operating temperature. It takes the unit approximately 120 seconds to reach the highest operating
temperature of 200°C. The high temperature setting will improve gutta percha ow, especially when used in the cold practice block (sold separately).
Begin by lling the plastic practice blocks with gutta percha per the instructions included. Use condensers to condense the material void free.
We recommend the Obtura Spartan S-Kondenser (available in 3 sizes).
• The soft silver applicator needles are designed to conduct heat to insure even at the needle tip; however, as the needle tip cools
between uses, you should express 3 cm of gutta percha to pre-heat the tip just prior to use. The needles are bendable to t the tooth,
however, they may break if they are repeatedly bent or if they are bent at the needle attachment point. Always use the Multi-Tool to bend
the needle. Do not kink the needle, as any restriction will impede ow. After a few practice sessions, proper needle bending will be easily
accomplished. Obtura Applicator Needles are designed for one use only.
• Do not loosen or remove the blue plastic Heater Nut. The Heater Nut is fastened to the gun with a set-screw; removal of the heater nut will
cause damage. The Heater Nut must be kept tightly fastened in order to secure the heater to the handpiece when expressing gutta percha.
• The stand for the handpiece may be positioned by itself or it may be attached to the bottom of the control unit. The stand can be attached to
either side of the control unit with four phillips-head screws that are fastened to the bottom of the stand (see page 5 for further details).
• The cord to the handpiece can extend from the front or rear of the unit. If a front exit is desired, gently press the handpiece cable into the
tracks on the bottom of the unit, to exit either on the left-front or the right-front (see page 5).
• Cleaning the Obtura III MAX is simple but very important; just follow the directions in this manual (see page 7) or on the provided laminated
cleaning instruction card. If your Obtura III MAX is cleaned on a regular basis it will provide years of reliable service. If you do not clean your
unit, it may become clogged and difcult to move the plunger due to a buildup of old, hardened gutta percha.
Thank you for purchasing the Obtura III MAX. We believe it is a benecial instrument that will enhance your practice. We are continually striving
to improve our products and services. If you have any questions or suggestions, we would appreciate hearing from you. We are also interested in
seeing any X-rays you may have of interesting cases. Feel free to contact us at: 1-800-344-1321 (or 1-877-485-3556 in Canada); we welcome the
opportunity to speak with you. Also, visit our website at: www.obtura.com.

OPERATOR’S MANUAL HEATED GUTTA PERCHA SYSTEM
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QUICK START GUIDE
1. Insert the hand piece cord connector into the hand piece cord port on the rear of the main control unit.
(Follow the cord-label instructions, or you may follow the “Handpiece Attachment/Detachment” instructions on page 10).
2. Insert the power supply connector into the power supply port. Then plug the power supply into the appropriate electrical outlet.
Use the appropriate interchangeable electric adapter. See page 5 for details.
3. Use the buttons as described in the picture below to operate your new Obtura III MAX System.
More detail on setup and operation is included in this manual. You may also follow the product diagram
located on the opposite side of the provided laminated cleaning instruction card.
HEATED GUTTA PERCHA SYSTEM
The Obtura III MAX is intended to be used by professionally-qualied dentists, endodontists and dental clinicians for specialty procedures in root
canal and restorative dentistry.
This equipment conforms to the requirements of the Medical Devices Directive 93/4 2/EEC and satises the electrical safety requirements of
EN 60601-1 and electromagnetic emissions and immunity standards of EN 60601-1-2.
This equipment is not suitable for use in the presence of ammable anesthetics.
Model 823-800 DC 12V, 1.0A. Medical Device Class Ila. Electrical Class II equipment. Type BF Applied Part.
Instructions for cleaning and a product diagram are also included on a separate laminated sheet.
The precision of the indicated value of temperature is +/- 5°C.
Use accessories manufactured or supplied by Young Innovations, Inc. only.
This equipment contains no electrical parts serviceable by the user.
Environmental Conditions Normal Use Transport and Storage
Ambient Temperature +10°C to 40°C-5°C to + 50°C
Relative Humidity 30% to 75%, non-condensing 30% to 75%
Atmospheric Pressure 860 hPa to 1060 hPa 700 hPa to 1600 hPa

OPERATOR’S MANUAL HEATED GUTTA PERCHA SYSTEM
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SYSTEM DESCRIPTION
The Obtura III MAX is intended for use by professionally-qualied dentists, endodontists and dental clinicians to heat gutta percha and to place it
into the previously prepared root canals of human teeth, in order to provide quick and complete obturation of the root canal.
There is a minimum level of understanding and background assumed in the descriptions and instructions found in this manual; if at any time you
feel overwhelmed or unsure of how to properly operate your Obtura III MAX unit, immediately cease use and call Obtura Spartan for assistance.
We value safety rst and foremost.
The Obtura III MAX features an interchangeable plug-in handpiece. Any Obtura III MAX handpiece will work with any Obtura III MAX base unit.
However, the Obtura III MAX handpiece cannot be retrot to the Obtura III or any other previous model.
The Obtura III MAX utilizes push-button digital temperature controls for more accurate, reproducible settings, and a memory function that stores
up to 5 user-selectable temperature settings for your convenience.
The Obtura III MAX complies with current Electromagnetic Compatibility standards (IEC 60601-1-2). The user should ensure that any possible
electromagnetic interference is not present, as it could potentially damage the device or any other electronic device in the vicinity.
UNPACKING AND ASSEMBLING
Check all packaging for signs of damage; report any damage with the shipping agent immediately, so that claims will be honored in a timely way.
Save all packing materials in the event of an instrument move or shipping at a later date (also see our “Greener Earth” commitment on the reverse
side of customer introductory letter).
Remove the clear plastic introduction bag, main control unit, handpiece, handpiece stand (complete with stand attachment spacer and screws),
power supply box, bagged supplies and accessory tool kit. Check for loose items.
Unwrap the main control unit and place on a at surface. Locate the unit so that by extending the cord you will not pull the unit OFF the surface.
The hand piece cable length is approximately 224 cm (88 in.).
Locate the handpiece stand and place it next to the main control unit. The stand provided for the handpiece can be attached to the Obtura III MAX
(if desired) by the following means:
After determining which side you want the stand placed on, simply remove the 2 screws on the bottom of the stand. After the screws are
removed hold the attachment plate to the bottom of the stand, and re-attach it to the desired location so it hangs off the side (as shown in
diagram A). Then attach the handpiece stand and bracket to the main control unit using the two remaining screws (see diagram B).
Plug the handpiece cord connector into the rear of the main control unit. Note: the alignment of the “red dot” at the 12 o’clock position, and a
“click” to signify complete insertion. Should the user require the cord to exit the front of the unit, invert the Obtura III MAX on a smooth, soft surface
and gently press the cable into the tracks provided, leaving a small loop of cable from the handpiece cord port to the beginning of the track. The cable
can exit on the left-front or the right-front (see diagram C), or from the rear (without use of the cable tracks).
Open the white power supply box and remove the power supply unit and receptacle blades. Choose the correct blade to t your electrical outlet and
slide it on to the power supply unit. Plug the power supply connector into the power supply port at the rear of the main control unit; plug the power
supply unit into an electrical outlet. The Obtura III MAX screen will momentarily light up, indicating the version of installed rmware, and then turn
OFF. This only occurs when rst connecting the main control unit to the electrical outlet.
A
B C
OPERATION
Operation of the Obtura III MAX has been designed to be intuitive, however, to fully realize the extent of the instrument and its many features,
please read this entire section.
There are four (4) tactile switches on the front of the Obtura III MAX and an LCD display. The functions of the four switches are: Power ON/OFF,
Temperature Up, Temperature Down and Temperature Memory (as shown in the “Quick Start Guide” section). When the Obtura Ill MAX is activated,
the 3-digit display will indicate the current operating temperature in degrees centigrade, and any memory presets desired. Description of each
button follows:
• Press the Power ON/OFF button to activate the Obtura III MAX. The display will show the last used set-point temperature. After 5-seconds,
the actual heater temperature will be displayed, heating up to the set-point. Press the Power button again to toggle OFF.

OPERATOR’S MANUAL HEATED GUTTA PERCHA SYSTEM
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• With the unit ON, press the Temperature Up(+) button to increase the set-point temperature in single degree increments.
Press the Temperature Down(-) button to reduce the set-point temperature, also in one degree increments.
• The Temperature Memory button retrieves preset memory set-points. A quick press of this button displays the letter “M” and the preset
position number. The temperature associated with the memory setting is displayed on the three-digit display. To set the unit to this
temperature, no other action is required, and after 5 seconds, it will now be the new set-point temperature and will be indicated on the unit
screen. To access another memory position, again press the Temperature Memory button to display the desired memory setting, and again
within 5-seconds, the unit will set to the next positioned temperature.
• To reset a memory location, press the Temperature Memory button until the preset position number you want to modify is shown. Then, within
5 seconds, adjust the preset temperature with the Temperature Up(+) and Temperature Down(-) buttons. The memory and the display are now
set to the new temperature. After 5 more seconds, with no button pressed, the Obtura III MAX display will change from the previously set
temperature to the new set-point temperature. Note: preset memories are saved even during power failure.
The Obtura III MAX requires approximately 120 seconds to heat from ambient room temperature of about 25°C, to maximum operating temperature
of 200°C.
For your convenience, the table below can be used as a reference:
Memory Number Factory Preset New Setting Date
M1 140°C
M2 150°C
M3 170°C
M4 180°C
M5 200°C
INSTALLING A NEEDLE
To place the gutta percha where desired in the root canal, choose an applicator needle diameter best suited (20, 23 or 25-gauge). With the Obtura Ill MAX
off and cool, remove the needle nut using the Multi-Tool; the needle nut should remain on the Multi-Tool when unscrewed. Place the appropriate needle
in the rear of the needle nut, so that the length of the needle protrudes through and forward (diagram G). Re-attach the needle nut on to the heater thread
using the Multi-Tool, making sure not to cross-thread (diagram H). Tighten until snug (do not over tighten, but do not leave too loose).
G H
BENDING THE NEEDLE
In most situations, a straight applicator needle will not provide access to the root canal. Using the Multi-Tool, gently bend the needle to provide
a shape conducive to the procedure (see diagram I). Be careful not to bend too sharply as kinks will result and gutta percha ow will be blocked.
For access to difcult to reach root canals, simply loosen the needle nut, rotate the needle to desired position, and then re-tighten.
I
LOADING GUTTA PERCHA
WARNING: USING MORE THAN ONE STICK OF GUTTA PERCHA AT A TIME MAY DAMAGE THE SEAL. DO NOT USE MORE THAN ONE
PIECE AT A TIME.
Power ON the Obtura Ill MAX and wait for the heater to come up to your desired temperature. Press the handpiece release button on the top of the
Obtura Ill MAX handpiece and withdraw the plunger shaft. Insert a gutta percha stick into the chamber via the opening just forward of the release
button (see diagram J). Re-insert the plunger shaft until the plunger seal engages the gutta percha pellet. Some resistance will be felt as the gutta
percha is pushed forward to the heating chamber.
J

OPERATOR’S MANUAL HEATED GUTTA PERCHA SYSTEM
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EXPRESSING GUTTA PERCHA
Specics to technique will not be addressed here, but a few reminders and hints follow:
• When expressing gutta percha, do not “withdraw” the Obtura Ill MAX, but let the gutta percha ll “push” the needle out of the canal.
Pulling the needle out may cause voids and require condensation or re-work.
• Take care when bending needles, as a kink will make it all but impossible to express material. Also, repeated bending will cause needle
weakening and subsequent breakage.
• Wait for the gutta percha to come up to full operating temperature before attempting to express; material that is too cool will require much
more pressure or may be impossible to pass through a small diameter applicator needle.
• Before beginning a procedure, express about 3 cm of gutta percha so that the up-to-temperature material will be at the end of the needle;
the warm material will ll space more completely.
STERILIZATION INSTRUCTIONS
The Obtura Thermal Protectors are designed to provide patient protection from the elevated temperatures of the heating chamber.
Patient contact requires that the Thermal Protectors be sterilized between uses to prevent cross-contamination issues.
Thermal Protector Sterilization Instructions:
1. Turn OFF the unit and allow it to cool to room temperature.
2. Using the Obtura Multi-Tool, disengage the tab on the rear of the thermal protector.
3. Pull the Thermal Protector off the front of the hand piece.
4. Place the Thermal Protector in a cassette-style autoclave at 132°C for 4 minutes.
NOTE: The Applicator Needle on the Obtura is not intended for multiple uses. It should be removed after a single use and disposed of. A new
Applicator Needle shall be used for each procedure. Failure to change the Applicator Needle increases the risk of cross-contamination during
a procedure.
5. After replacing the Applicator Needle, Reinstall the Thermal Protector by pressing it onto the front of the hand piece. Be careful of the Applicator
Needle as it is capable of injuring your hand.
By steam sterilizing the Thermal Protector and using a new Applicator Needle every time, you are greatly reducing the chance of any cross-
contamination to your patients.
If you have any questions regarding this or any other aspect of using the Obtura System, please call us at 1-800-344-1321.
MAINTENANCE
For best results, the Obtura III MAX handpiece should be cleaned daily. This prevents build-up of excess gutta percha within the heating chamber.
Regular Maintenance (Day to Day Cleaning)*
Tools you will need:
• Multi-Tool
• Cleaning brush and Cleaning solution
• Disposable cloth (napkin, gauze, etc.)
1. Prior to cleaning, ensure that your Obtura Ill MAX unit is turned OFF, fully cooled and unplugged.
2. Unlatch and remove the thermal protector using the Multi-Tool.
3. A) Use the Multi-Tool to unscrew the needle nut from the heater thread.
B) Set aside the needle nut. Dispose of the needle (for optimum performance, Obtura Applicator Needles should be used only once).
4. Extrude all remaining gutta percha by squeezing the handpiece trigger. The gutta percha will come out in solid pellet form.
5. Push and hold the release button, removing the plunger shaft from the handpiece.
6. A) Inspect the plunger seal for gutta percha.
B) If gutta percha is present, dip the cleaning brush into the cleaning solution, fully coating the brush.
C) Clean the plunger seal with the cleaning brush in a back and forth motion until all visible gutta percha is cleared.
7. A) Inspect the inside of the hand piece shaft for any visible gutta percha.
B) If gutta percha is present, re-dip the cleaning brush into the cleaning solution, fully coating the brush.
C) Place the cleaning brush inside the handpiece shaft and clean in a back and forth motion until all visible gutta percha is cleared.

OPERATOR’S MANUAL HEATED GUTTA PERCHA SYSTEM
Page 8
8. A) Reassemble all components in the reverse order from which they were detached.
B) Place the handpiece back on its cradle.
WARNING: AT NO POINT SHOULD ANY PART OF THE OBTURA III MAX HANDPIECE BE SUBMERGED INTO THE CLEANING SOLUTION.
NOTE: A) For optimal cleaning, use a Birex®-type solution to aid in disinfecting and deodorizing your Obtura III MAX unit.
B) Never spray the disinfectant solution directly on to the unit; always spray into a disposable cloth, then wipe down.
*The above regular maintenance cleaning instructions are also displayed on the provided laminated cleaning instruction card, which contains visual diagrams for your convenience.
EXTENDED MAINTENANCE
As Needed for:
• Repeated plunger seal failure
• The plunger shaft repeatedly gets stuck in handpiece
• The cleaning brush is ineffective in removing excess gutta percha from the handpiece shaft during normal cleaning
Tools you will need:
• Multi-Tool
• Cleaning brush and Cleaning solution
• Disposable cloth (napkin, gauze, etc.)
• Heater Reamer Tool*
1. Prior to cleaning, ensure that your Obtura III MAX unit is turned OFF and fully cooled.
2. Unlatch and remove the thermal protector using the Multi-Tool.
3. Use the Multi-Tool to unscrew the needle nut from the heater thread. Set aside the needle nut. Dispose of the needle (for optimum performance,
Obtura Applicator Needles should be used only once).
4. Tum the unit back ON and allow it to reach full operating temperature (200°C) in order to loosen residual gutta percha.
5. Once the full operating temperature is reached, tum OFF the unit and unplug.
6. Immediately extrude all remaining gutta percha into a disposable cloth by squeezing the handpiece trigger.
WARNING: CONTENTS WILL BE EXTREMELY HOT!
7. Push and hold the release button, removing the plunger shaft from the handpiece. Visually inspect the plunger seal to determine if a replacement
is necessary (example: metal threads at the tip of the plunger shaft are exposed or there is other obvious erosion).
8. Using the heater reamer tool, clean the handpiece shaft in a back and forth motion until all visible gutta percha is cleared.
9. Dip the cleaning brush into the cleaning solution, fully coating the brush. Clean the handpiece shaft with the cleaning brush in a back and forth
motion until all excess gutta percha is cleared.
10. Reassemble all components in the reverse order from which they were detached. Place the handpiece back on its cradle.
WARNING: AT NO POINT SHOULD ANY PART OF THE OBTURA Ill MAX HANDPIECE BE SUBMERGED INTO THE CLEANING SOLUTION.
NOTE: A) For optimal cleaning, use a Birex®-type solution to aid in disinfecting and deodorizing your Obtura III MAX unit.
B) Never spray the disinfectant solution directly on to the unit; always spray into a disposable cloth, then wipe down.
*The heater reamer tool should only be used as needed.
The Thermal Protectors must sterilized before use.
HANDPIECE BUSHING
Handpiece Bushing is susceptible to wear caused by the bushing misalignment. This causes the trigger pawl to wear at the pawl engagement
opening. The bushing should be aligned in the handpiece so that bushing rotation ceases. To install the handpiece bushing, slide it in the opening at
the rear of the handpiece (diagram K), and turn clockwise until resistance is felt. The handpiece bushing should be cleaned or replaced as needed.
K

OPERATOR’S MANUAL HEATED GUTTA PERCHA SYSTEM
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PLUNGER SHAFT ASSEMBLY
Areas of inspection consist of the plunger seal and the plunger teeth. The plunger seal should be inspected for wear or breakage. Gutta percha
expressed through the handpiece will give a quick and accurate indication of the plunger seal’s condition. If excessive gutta percha passes by the seal,
the plunger seal assembly should be replaced. The plunger teeth should be inspected for wear or chipping. The plunger shaft should be replaced if
plunger teeth are badly chipped or slipping occurs during testing. The plunger shaft of the Obtura III MAX should be checked for bending; if it will not
roll smoothly on a piece of glass or at tabletop (indicating a bow or bend), it should be replaced, as the use of a bent shaft may cause damage to the
heater bore.
PLUNGER SEAL ASSEMBLY
To remove the plunger seal assembly, rst locate the Multi-Tool’s small hex shape opening (diagram L). Then heat the end of the plunger shaft
(a lighter will work; please use precaution) to soften the thread-locker. After the thread-locker softens, carefully insert the plunger seal assembly
within the hex shape opening, and unscrew the plunger seal assembly from the plunger shaft (diagram M). To replace the assembly, thoroughly
clean the end of the plunger, using extra care, to be sure the threads are clean and dry. Re-apply and tighten the plunger seal assembly using the
Multi-Tool’s hex utility once again. Do not over-tighten.
L
M
NEEDLE NUT
The needle nut may become lled with gutta percha, which will inhibit complete tightening and thermal transfer from the heater to the applicator
needle. The needle nut threads can be cleaned with a 1/4-28 tap, but it’s usually more efcient to replace it. The needle nuts can be collected and
cleaned thoroughly at a later date for re-use. If the needle nut does become lled with gutta percha, it may indicate that the needle nut has been
tightened insufciently. Use the Multi-Tool to assure proper t.
HANDPIECE CABLE ASSEMBLY
The handpiece cable should be thoroughly inspected at the handpiece entry point for broken wires and cracks in the cable housing (may be due
to the frequent bending in this area). These signs are an intermittent problem where the unit will work ne initially, but when the handpiece cable is
bent, the unit stops heating altogether. If these conditions exist, the error codes on the Obtura III MAX display can diagnose them (see error codes).
Error Codes
Error Code Fault Remedy
S-1 Handpiece Disconnected
(communication failure)
1) Verify tment of handpiece connector
2) Remove and replace
3) Check cable for breaks or damage
4) Check connector for broken or bent pins
5) Contact factory for handpiece repair/replacement
S-2 Cannot Reach Temperature in 255 sec Heater fault - Contact factory for repair
H-1 Heater Wire Open Replace handpiece or contact factory for repair guidance
H-2 Heater Wire Short Replace handpiece or contact factory for repair guidance
H-3 Thermocouple Error Replace handpiece or contact factory for repair guidance
B-1 Internal Control Base Failure Not user-serviceable - Contact factory for repair
P-1 Power Supply Fault Replace power supply or contact factory for repair guidance

OPERATOR’S MANUAL HEATED GUTTA PERCHA SYSTEM
Page 10
HANDPIECE ATTACHMENT/DETACHMENT
To Attach: Hold the handpiece cord connector at the rear of the main control unit, facing the triangle indicator at the 12 o’clock position
(see diagram N). Plug in to the handpiece cord port when proper alignment is reached.
To Detach: Squeeze the serrated section on the handpiece cord connector (by the triangle) and gently pull back (see diagram O).
Connector does not turn.
N O
THEORY OF OPERATION
The heating system of the Obtura Ill MAX is a closed-loop design to ensure consistent temperatures and uniform gutta percha ow. This means the
temperature of the heater is read several hundred times per second and corrected (as necessary) to insure accurate and consistent heating.
In the handpiece, the temperature of the heating chamber is detected by a thermocouple integrated into the heating element and encapsulated with
epoxy. The output from the thermocouple is converted by an analogue-to-digital converter, and into a digital stream for use by the main control unit.
The handpiece is composed of a two-piece heat-resistant composite body that encapsulates the trigger assembly heater system and plunger.
Gutta percha is placed into the top of the handpiece shell and expressed via the plunger shaft assembly Pressing the handpiece trigger, which pushes
the shaft via a spring-loaded pawl, moves the shaft forward. The heater assembly is directly connected to the handpiece shell, providing a straight
through path for gutta percha, warming it in the process.
In the control unit, the data stream from the handpiece is read and the temperature interpreted by a micro controller. This builds display data for the
LCD and reads the touch-panel. The processor also turns the heating element ON and OFF several hundred times per second to maintain constant
temperature. A “watchdog” processor performs self-diagnostics for the system.
Power supply voltage never enters the Obtura III MAX, as the voltage is converted to 12-volts DC via an external switch mode power supply.
Selection and installation of the appropriate plug blade is all that is necessary to congure the unit. Low-voltage enters the control unit case via a
“standard” power supply connector.
FREQUENTLY ASKED QUESTIONS
Q. How often should the unit be cleaned?
A. The Obtura III MAX should be cleaned at the end of each day or procedural session (see page 7).
Q. How often should the applicator needle be changed?
A. The applicator needle must be changed after each patient operation and when damage is detected or suspected. This is to ensure proper
operation and to prevent the spread of infectious diseases.
Q. How often should the plunger seal be changed?
A. Observe seal for wear; replace if seal is tom or missing (see page 8).
Q. Why should I only use one pellet of gutta percha?
A. Critical lengths of the mechanical components of the Obtura III MAX have been designed for a single piece of gutta percha; using more can
cause excessive back pressure and damage (see pages 6-7).
Q. ls the Obtura III MAX Handpiece Autoclavable?
A. No, the Obtura III MAX handpiece is not autoclavable. It should be cleaned using a BIREX-type solution. Only the thermal protectors are
autoclavable, once removed from the handpiece.
Q. The handpiece trigger is not working, how can I x it?
A. Incorrect bushing installation can cause the trigger not to work. Make sure the bushing is installed with the small indicator line at the 12’ o’clock
position at the back of the handpiece (see page 8).
Q. Can I leave the needle nut loose so that it can be rotated during use?
A. No, the needle nut is not designed to be used in this manner. The needle nut must always be tightened securely before extruding gutta percha
(see page 5).
Q. How do I disconnect the Obtura III MAX Handpiece Connector from the base unit?
A. Squeeze the serrated section on the handpiece cord connector (by the triangle) and gently pull back. Connector does not tum (see page 9).
Q. Can I use the Obtura III MAX if the display is showing an Error Code?
A. No, your Obtura III MAX unit should be evaluated and repaired if it is displaying an error code on the screen (see page 9).

OPERATOR’S MANUAL HEATED GUTTA PERCHA SYSTEM
Pa g e 11
Q. Is there any way to reduce the force required to extrude gutta percha?
A. Yes, a few options exist. You may try to increase the operating temperature to improve the ow ability of our standard gutta percha.
Obtura Spartan also sells Flow 150 gutta percha and Resinate pellets that may ow more easily than the standard gutta percha.
FACTORY REPAIR/CONTACT US
Factory Service is available at Young Innovations, Inc. Please call the number below for technical support and problem diagnosis.
Young Innovations, Inc.
[phone]
www.obtura.com
It is necessary to acquire an RMA number before returning your unit. Failure to do this may result in longer repair times and additional charges.
If you have spoken to the repair department and it is determined that the unit must be returned to the factory, please be sure to pack carefully and
appropriately. Use the original box and packaging (if possible), or a minimum of 8 cm (3 in.) impact-absorbing insulation in your new box.
Obtura Spartan will not be responsible for damage due to improper packing or shipping. Insurance is optional and highly recommended.
Note: Unauthorized repair will void all warranties. Authorized repair procedures must follow all safety precautions. Be sure that the power supply
connector is disconnected from the power supply port before authorized repairs, and that safety glasses are worn at all times during the authorized
repair procedures.
REPLACEMENT PARTS
Part Number Description Part Number Description
823-800 Obtura III MAX Complete System 822-609 Obtura Cleaning Kit - Bottle of Cleaning
Solution with 2 Brushes
823-810 Obtura Ill MAX Handpiece 822-613 Obtura Cleaning Brushes - Pack of 2
823 -711 Obtura Power Supply 825-103 Obtura Heater Reamer Tool
823-815 Obtura III MAX Thermal Protectors -
Pack of 4 823-620 Obtura Applicator Needles - 20 Gauge
823-616 Obtura Needle Nuts - Pack of 2 823-623 Obtura Applicator Needles - 23 Gauge
823-618 Obtura Plunger Seal Assembly 823-635 Obtura Applicator Needles - 25 Gauge
823-812 Obtura III MAX Plunger Shaft
with Plunger Seal 822-602 Obtura Gutta Percha - Box of 100 Pieces
823-814 Obtura Ill MAX Handpiece Bushing 822-604 Obtura Flow 150 Gutta Percha -
Box of 100 Pieces
823-813 Obtura III MAX Multi-Tool

OPERATOR’S MANUAL HEATED GUTTA PERCHA SYSTEM
Page 12
EMC TABLE
IEC 60601-1-2:2007 (Ed 3.0)
GUIDANCE AND MANUFACTURER ‘S DECLARATION - ELECTROMAGNETIC EMISSIONS
The Obtura Ill Max Heated Gutta Percha System is intended for use in the electromagnetic environment specied below.
The customer or the user of the Obtura Ill Max Heated Gutta Percha System should assure that it is used in such an environment.
Emission Test Compliance Electromagnetic Environment - Guidance
RF Emission
CISPR 11 Group 1
The Obtura Ill Max Heated Gutta Percha System 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 electronic
equipment.
RF Emissions
CISPR 11 Class B
The Obtura Ill Max Heated Gutta Percha System 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 IEC 61000-3-2 Class A
Voltage uctuations/icker emissions
IEC 61000-3-3 Complies
GUIDANCE AND MANUFACTURER ‘S DECLARATION - ELECTROMAGNETIC IMMUNITY
The Obtura Ill Max Heated Gutta Percha System is intended for use in the electromagnetic environment specied below.
The customer or the user of the Obtura Ill Max Heated Gutta Percha System should assure that it is used in such an environment.
Immunity Test IEC 60601
Test Level Compliance Level Electromagnetic Environment - Guidance
Electrostatic discharge (ESD)
IEC 61000-4-2
±6 kV contact
±8kV air
±2, 4, 6 kV contact
± 2, 4, 6, 8 kV air
Floor should be wood, concrete or ceramic tile. If oors
are covered with synthetic material, the relative humidity
should be at least 30 %.
Electrical fast transient/burst
IEC 61000-4-4
± 2 kV for power
supply lines
± 1 kV for input/
output lines
± 2 kV for power
supply lines
± 1 kV for input/
output lines
Mains power quality should be that of a typical
commercial or hospital environment.
Surge
IEC 61000-4-5
± 1 kV line(s) to
line(s)
± 2 kV line(s) to
earth
± 1 kV line(s) to
line(s)
± 2 kV line(s) to
earth
Mains power quality should be that of a typical
commercial or hospital environment.
Voltage dips, short interruptions
and voltage variations on power
supply input lines
IEC 61000-4-11
<5% UT(>95% dip in
UT) for 0.5 cycle
40% UT(60% dip in
UT) for 5 cycles
70% UT(30% dip in
UT) for 25 cycles
<5% UT(>95% dip in
UT) for 5 sec
100% dip in UT
for 0.5 cycle
60% dip in UT
for 5 cycles
30% dip in UT
for 25 cycles
100% dip in UT
for 5 sec
Mains power quality should be that of a typical
commercial or hospital environment. If the user of the
Obtura Ill Max Heated Gutta Percha System requires
continued operation during power mains interruptions,
it is recommended that the Obtura Ill Max Heated Gutta
Percha System be powered from an uninterruptible power
supply or a battery.
Power frequency (50/60 Hz)
magnetic eld
IEC 61000-4-8
3A/m 3A/m
Power frequency magnetic elds should be at levels
characteristics of a typical location in a typical
commercial or hospital environment.
NOTE: UTis the (AC) mains voltage prior to application of the test level.

OPERATOR’S MANUAL HEATED GUTTA PERCHA SYSTEM
Page 13
GUIDANCE AND MANUFACTURER ‘S DECLARATION - ELECTROMAGNETIC IMMUNITY
The Obtura Ill Max Heated Gutta Percha System is intended for use in the electromagnetic environment specied below.
The customer or the user of the Obtura Ill Max Heated Gutta Percha System should assure that it is used in such an environment.
Immunity Test IEC 60601
Test Level Compliance Level Electromagnetic Environment - Guidance
Conducted RF
IEC 61000·4·6
Radiated RF
IEC 61000·4·3
3Vrms
150 kHz to 80 MHz
3V/m
80 MHz to 2.5 GHz
3 V
3 V/m
Portable and mobile RF communications equipment
should be used no closer to any part of the Obtura III Max
Heated Gutta Percha System including cables, than the
recommended separation distance calculated from the
equation applicable to the frequency of the transmitter.
Recommended separation distance
d= 1.2 √P
d= 1.2 √P80 MHz to 800 MHz
d= 2.3 √P800 MHz to 2.5 GHz
Where Pis 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 strength from xed RF transmitters, as determined
by an electromagnetic site survey, ashould be less than
the compliance level in each frequency range. b
Interference may occur in the vicinity of equipment
marked with the following symbol.
NOTE 1: At 80 MHz and 800 MHz, the higher frequency range applies
NOTE 2: These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reection from structures,
objects and people.
a
Field strengths from xed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobile radios, amateur radio, AM
and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy. To assess the electromagnetic environment due to
xed RF transmitters, an electromagnetic site survey should be considered. If the measured eld strength in the location in which the Obtura Ill
Max Heated Gutta Percha System is used exceeds the applicable RF compliance level above, the Obtura Ill Max Heated Gutta Percha System
should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as re-
orienting or relocating the Obtura Ill Max Heated Gutta Percha System.
b
Over the frequency range 150 kHz to 80 MHz, eld strengths should be less than 3 V/m.

OPERATOR’S MANUAL HEATED GUTTA PERCHA SYSTEM
Page 14
RECOMMENDED SEPARATION DISTANCES BETWEEN PORTABLE AND MOBILE RF COMMUNICATIONS EQUIPMENT
AND THE OBTURA III MAX HEATED GUTTA PERCHA SYSTEM
The Obtura Ill Max Heated Gutta Percha System is intended for use in an electromagnetic environment in which radiated RF disturbances
are controlled. The customer or the user of the Obtura Ill Max Heated Gutta Percha System can help prevent electromagnetic interference
by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the Obtura Ill Max
Heated Gutta Percha System as recommended below, according to the maximum output power of the communications equipment.
Rated maximum output
power of transmitter
W
Separation distance according to frequency of transmitter
m
150 kHz to 80 MHz
d=1.2√P
80 MHz to 800
MHz
d=1.2√P
80 MHz to 800 MHz
d=2.3√P
0.01 0.12 0.12 0.23
0.1 0.38 0.38 0.73
11.2 1.2 2.3
10 3.8 3.8 7.3
100 12 12 23
For transmitters rated at a maximum output power not listed above, the recommended separation distance din meters (m) can be estimated
using the equation applicable to the frequency of the transmitter, where Pis the maximum output power rating of the transmitter in watts (W)
according to the transmitter manufacturer.
NOTE 1: At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies.
NOTE 2: These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reection from structures,
objects and people.

OPERATOR’S MANUAL HEATED GUTTA PERCHA SYSTEM
Page 15
Symbol Description Symbol Description
See instructions for use Class II Equipment
Single use, do not re-use Use by
Steam sterilize at the temperature indicated Caution: Federal Law restricts this device to sale by or
on the order of a dentist
Do not dispose of this equipment as unsorted
municipal waste, it is to be collected separately.
Consult local regulation for disposal.
+48°C
-17°C
Temperature Up/Down represents the acceptable
temperature range for transportation of this device. Allow
unit to come to room temperature before use.
Batch or Lot code SN/PN Serial Number/Part Number
Mfg. Date Power On/Off
+/- Temperature Up/Down MMemory preset for temperature
REF Product reference number Medical Device
Type BF applied part
Young Innovations, Inc.
2260 Wendt Street
Algonquin, IL 60102 USA
www.obtura.com
MDSS GmbH
Schiffgraben 41
30175 Hannover
Germany
57412 Rev. K 11/20/2019Made in USA
2797

OPERATOR’S MANUAL HEATED GUTTA PERCHA SYSTEM
Page 16
Page 1
Section 1: IDENTIFICATION
Manufactured for:
Address:
City, State, Zip:
Telephone:
Product Item No.:
Product Name/Identier:
Common Name:
Chemical Name:
Product Use:
24 hr EMERGENCY
PHONE #
Young Innovations, Inc. - dba Obtura
2260 Wendt Street
Algonquin, IL 60102 USA
1-800-275-0020
822-609, 3069-01A, 823-703, 823-803
Obtura Cleaning Solution
Obtura Cleaning Solution
d-Limonene / hydrocarbon mixture
A solvent degreasing agent for removing tar, adhesives, grease, oil and other
residues from metal and other hard surfaces.
INFOTRAC 1-800-535-5053
Outside U.S. 1-352-323-3500
Section 2: HAZARD(S) IDENTIFICATION
PHYSICAL HAZARDS
Flammable aerosols: Category 1
Gases under pressure: Compressed gas
HEALTH HAZARDS
Skin corrosion/irritation: Category 2
Serious eye damage/eye irritation: Category 2
Sensitization, skin: Category 1
ENVIRONMENTAL HAZARDS
Not classied.
OSHA DEFINED HAZARDS
Not classied.
LABEL ELEMENTS
Signal Word: Danger
Hazard statement: Extremely ammable aerosol. Contains gas under pressure; may explode if heated. Causes skin irritation. Causes serious eye irritation. May cause an
allergic skin reaction.
PRECAUTIONARY STATEMENT
Prevention
Keep away from heat/sparks/open ames/hot surfaces. - No smoking. Do not spray on an open ame or other ignition source. Pressurized container: Do not pierce
or burn, even after use. Wear eye/face protection. Avoid breathing gas. Wash thoroughly after handling. Contaminated work clothing must not be allowed out of the
workplace. Wear protective gloves.
Response
If on skin: Wash with plenty of water. If skin irritation or rash occurs: Get medical advice/attention. Take o contaminated clothing and wash before reuse. Specic
treatment (see this label).
If in eyes: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing. If eye irritation persists: Get medical
advice/attention.
Storage
Store in a well-ventilated place. Protect from sunlight. Do not expose to temperatures exceeding 50°C/122°F.
Disposal
Dispose of contents/container in accordance with local/regional/national/international regulations.
HAZARD(S) NOT OTHERWISE CLASSIFIED (HNOC): None known.
SUPPLEMENTAL INFORMATION: Not applicable.
SAFETY DATA SHEET

OPERATOR’S MANUAL HEATED GUTTA PERCHA SYSTEM
Page 17
Page 2
Section 3: COMPOSITION/INFORMATION ON INGREDIENTS
MIXTURES
CHEMICAL NAME COMMON NAME AND SYNONYMS CAS NUMBER %
Distillates Petroleum Hydrotreated Light 64742-47-8 60 - 70
3-Methoxy-3-methyl-1-butanol (MMB) 56539-66-3 10 - 20
d-limonene 5989-27-5 10 - 20
Carbon Dioxide 124-38-9 1 - 3
Section 4: FIRST AID MEASURES
Inhalation: Remove victim to fresh air and keep at rest in a position comfortable for breathing. Oxygen or articial respiration if needed.
Do not use mouth-to-mouth method if victim inhaled the substance.
Induce articial respiration with the aid of a pocket mask equipped with a one-way valve or other proper respiratory medical device. Call a POISON CENTER or doctor/
physician if you feel unwell.
Skin: In case of contact, immediately ush skin with plenty of water for at least 15 minutes while removing contaminated clothing and shoes. Get medical attention if
irritation develops and persists.
Eye contact: Immediately ush with plenty of water for at least 15 minutes. If easy to do, remove contact lenses. Get medical attention if irritation develops and persists.
Ingestion: Call a physician or poison control center immediately. Only induce vomiting at the instruction of medical personnel. Never give anything by mouth to an
unconscious person. If vomiting occurs, keep head low so that stomach content doesn’t get into the lungs.
Most important symptoms/eects, acute and delayed: Irritant eects. Symptoms may include stinging, tearing, redness, swelling, and blurred vision.
Defatting of the skin. Rash. Symptoms of overexposure can include shortness of breath, drowsiness, headaches, confusion, decreased coordination, visual disturbances
and vomiting, and are reversible if exposure is stopped.
Indication of immediate medical attention and special treatment needed: Provide general supportive measures and treat symptomatically. In case of shortness of
breath, give oxygen. Keep victim under observation. Symptoms may be delayed.
General information: In the case of accident or if you feel unwell, seek medical advice immediately (show the label where possible). Ensure that medical personnel are
aware of the material(s) involved, and take precautions to protect themselves.
Section 5: FIRE FIGHTING MEASURES
Suitable extinguishing media: Alcohol resistant foam. Water fog. Dry chemical powder. Carbon dioxide (CO2).
Unsuitable extinguishing media: Do not use water jet as an extinguisher, as this will spread the re.
Specic hazards arising from the chemical: Contents under pressure. Pressurized container may explode when exposed to heat or ame.
Special protective equipment and precautions for reghters: Fireghters must use standard protective equipment including ame retardant coat, helmet with face
shield, gloves, rubber boots, and in enclosed spaces, SCBA. Structural reghters protective clothing will only provide limited protection.
Fire ghting equipment/instructions: In case of re and/or explosion do not breathe fumes. Use standard reghting procedures and consider the hazards of other
involved materials. Move containers from re area if you can do so without risk. Water runo can cause environmental damage.
Specic methods: Use standard reghting procedures and consider the hazards of other involved materials. Move container from re area if it can be done without
risk. In the event of re and/or explosion do not breathe fumes.
General re hazards: Extremely ammable aerosol.
SAFETY DATA SHEET

OPERATOR’S MANUAL HEATED GUTTA PERCHA SYSTEM
Page 18
Page 3
Section 6: ACCIDENTAL RELEASE MEASURES
PERSONAL PRECAUTIONS, PROTECTIVE EQUIPMENT AND EMERGENCY PROCEDURES
Keep unnecessary personnel away. Keep people away from and upwind of spill/leak. Keep out of low areas. Eliminate all ignition sources (no smoking, ares, sparks,
or ames in immediate area). Wear appropriate personal protective equipment. Do not touch damaged containers or spilled material unless wearing appropriate
protective clothing. Avoid inhalation of vapors or mists. Ventilate closed spaces before entering them. Local authorities should be advised if signicant spillages cannot
be contained. Use personal protection recommended in Section 8 of the SDS.
METHODS AND MATERIALS FOR CONTAINMENT AND CLEANING UP
Eliminate all ignition sources (no smoking, ares, sparks, or ames in immediate area). Take precautionary measures against static discharge. Use only non-sparking tools.
Keep combustibles (wood, paper, oil, etc.) away from spilled material. This material is classied as a water pollutant under the Clean Water Act and should be prevented
from contaminating soil or from entering sewage and drainage systems which lead to waterways.
Large Spills: Stop the ow of material, if this is without risk. Dike the spilled material, where this is possible. Use a non-combustible material like vermiculite, sand or
earth to soak up the product and place into a container for later disposal. Use water spray to reduce vapors or divert vapor cloud drift. Following product recovery, ush
area with water.
Small Spills: Wipe up with absorbent material (e.g. cloth, eece). Clean surface thoroughly to remove residual contamination.
Never return spills in original containers for re-use. For waste disposal, see section 13 of the SDS.
ENVIRONMENTAL PRECAUTIONS
Avoid release to the environment. Contact local authorities in case of spillage to drain/aquatic environment. Prevent further leakage or spillage if safe to do so. Avoid
discharge into drains, water courses or onto the ground.
Section 7: HANDLING AND STORAGE
PRECAUTIONS FOR SAFE HANDLING: Do not handle, store or open near an open ame, sources of heat or sources of ignition. Protect material from direct sunlight.
Do not smoke. Take precautionary measures against static discharges. All equipment used when handling the product must be grounded. Use non-sparking tools and
explosion-proof equipment. Avoid breathing mist or vapor. Avoid contact with skin. Avoid contact with eyes. Avoid prolonged exposure. Provide adequate ventilation.
Wear appropriate personal protective equipment. Observe good industrial hygiene practices. Wash hands thoroughly after handling. Avoid release to the environment.
Do not empty into drains.
CONDITIONS FOR SAFE STORAGE, INCLUDING ANY INCOMPATIBILITIES: Level 3 Aerosol. Contents under pressure. Keep away from heat, sparks and open ame.
Keep container tightly closed. Store in a cool, dry place out of direct sunlight. Store in a well-ventilated place. Keep in an area equipped with sprinklers.
Section 8: EXPOSURE CONTROLS/PERSONAL PROTECTION
OCCUPATIONAL EXPOSURE LIMITS
US. OSHA Table Z-1 Limits for Air Contaminants (29 CFR 1910.1000)
COMPONENTS TYPE VALUE
Carbon Dioxide (CAS 124-38-9) PEL 9000 mg/m3
5000 ppm
US. ACGIH Threshold Limit Values
COMPONENTS TYPE VALUE
Carbon Dioxide (CAS 124-38-9) STEL
TWA
30000 ppm
5000 ppm
S. NIOSH: Pocket Guide to Chemical Hazards
COMPONENTS TYPE VALUE
Carbon Dioxide (CAS 124-38-9) STEL
TWA
54000 mg/m3
30000 ppm
9000 mg/m3
5000 ppm
BIOLOGICAL LIMIT VALUES: No biological exposure limits noted for the ingredient(s).
APPROPRIATE ENGINEERING CONTROLS: Good general ventilation (typically 10 air changes per hour) should be used. Ventilation rates should be matched to
conditions. If applicable, use process enclosures, local exhaust ventilation, or other engineering controls to maintain airborne levels below recommended exposure
limits. If exposure limits have not been established, maintain airborne levels to an acceptable level.
INDIVIDUAL PROTECTION MEASURES, SUCH AS PERSONAL PROTECTIVE EQUIPMENT
Eye/face protection: Wear safety glasses with side shields (or goggles). Eye wash fountain is recommended.
Skin protection
Hand protection: Chemical resistant gloves are recommended.
Other: Avoid contact with clothing. Wear suitable protective clothing. Chemical resistant gloves.
SAFETY DATA SHEET

OPERATOR’S MANUAL HEATED GUTTA PERCHA SYSTEM
Page 19
Page 4
(continued) Section 8: EXPOSURE CONTROLS/PERSONAL PROTECTION
Respiratory protection: No personal respiratory protective equipment normally required. Use a positive-pressure air-supplied respirator if there is any potential for an
uncontrolled release, exposure levels are not known, or any other circumstances where air-purifying respirators may not provide adequate protection.
Thermal hazards: Not applicable.
General hygiene considerations: When using, do not eat, drink or smoke. Always observe good personal hygiene measures, such as washing after handling the
material and before eating, drinking, and/or smoking. Routinely wash work clothing and protective equipment to remove contaminants.
Section 9: PHYSICAL & CHEMICAL PROPERTIES
Appearance
Physical state: Gas.
Form: Aerosol.
Color: Clear, O-white.
Upper/lower ammability or explosive limits
Flammability limit - lower (%): 0.7 %
Flammability limit - upper (%): 6 %
Explosive limit - lower (%): Not available.
Explosive limit - upper (%): Not available.
Odor: Orange Vapor pressure: < 5 mm Hg @ 20°C
Odor threshold: Not established Vapor density: > 1 (air = 1)
pH: Not applicable Relative density: Not available.
Melting point/freezing point: Not established Solubility(ies) Solubility (water): < 15 %
Initial boiling point and boiling range: > 302 °F (> 150 °C) Partition coecient (n-octanol/water): Not established
Flash point: 104.0 °F (40.0 °C) Tag Closed Cup Auto-ignition temperature: > 392 °F (> 200 °C)
Evaporation rate: > 0.1 BuAc Decomposition temperature: Not established
Flammability (solid, gas): Not available. Viscosity: < 3 cSt @ 25°C
Other information
Heat of combustion: > 30 kJ/g
Percent volatile: 100 %
Specic gravity: 0.82 - 0.86 @ 20°C
VOC (Weight %): 97.2 % per U.S. State and Federal Consumer Product Regulations CARB
Section 10: STABILITY & REACTIVITY
Reactivity: The product is stable and non-reactive under normal conditions of use, storage and transport.
Chemical stability: Material is stable under normal conditions.
Possibility of hazardous reactions: Hazardous polymerization does not occur.
Conditions to avoid: Heat, ames and sparks. Avoid temperatures exceeding the ash point.
Incompatible materials: Strong oxidizing agents.
Hazardous decomposition products: Carbon oxides.
Section 11: TOXICOLOGICAL INFORMATION
Information on likely routes of exposure
Inhalation: May cause irritation to the respiratory system.
Skin contact: Causes skin irritation. May cause sensitization by skin contact.
Eye contact: Causes eye irritation.
Ingestion: May cause discomfort if swallowed. However, ingestion is not likely to be a primary route of occupational exposure.
Symptoms related to the physical, chemical and toxicological characteristics: Irritant eects. Symptoms may include stinging, tearing, redness, swelling, and blurred
vision. Defatting of the skin. Symptoms of overexposure may be headache, dizziness, tiredness, nausea and vomiting.
Information on toxicological eects
Acute toxicity: Based on available data, the classication criteria are not met.
COMPONENTS SPECIES TEST RESULTS
3-Methoxy-3-methyl-1-butanol (MMB) (CAS 56539-66-3)
Acute
Dermal
LD50 Rat > 2000 mg/kg, 24 Hours
SAFETY DATA SHEET

OPERATOR’S MANUAL HEATED GUTTA PERCHA SYSTEM
Page 20
Page 5
(continued) Section 11: TOXICOLOGICAL INFORMATION
COMPONENTS SPECIES TEST RESULTS
Distillates Petroleum Hydrotreated Light (CAS 64742-47-8)
Acute
Dermal
LD50 Rabbit > 2000 mg/kg
> 2000 mg/kg, 24 Hours
Inhalation
LC50
Oral
LD50
Cat
Rat
Rat
> 6.4 mg/l, 6 Hours
> 7.5 mg/l, 6 Hours
> 4.3 mg/l, 4 Hours
> 0.1 mg/l, 8 Hours
> 5000 mg/kg
d-limonene (CAS 5989-27-5)
Acute
Oral
LD50 Mouse
Rat
5600 - 6600 mg/kg
> 2000 mg/kg
Skin corrosion/irritation: Causes skin irritation.
Serious eye damage/eye irritation: Causes serious eye irritation.
Respiratory or skin sensitization
Respiratory sensitization: Based on available data, the classication criteria are not met.
Skin sensitization: May cause sensitization by skin contact.
Germ cell mutagenicity: No data available to indicate product or any components present at greater than 0.1% are mutagenic or genotoxic.
Carcinogenicity: Based on available data, the classication criteria are not met.
IARC Monographs. Overall Evaluation of Carcinogenicity: d-limonene (CAS 5989-27-5) 3 Not classiable as to carcinogenicity to humans.
OSHA Specically Regulated Substances (29 CFR 1910.1001-1050): Not listed.
Reproductive toxicity: Based on available data, the classication criteria are not met.
Specic target organ toxicity - single exposure: Based on available data, the classication criteria are not met.
Specic target organ toxicity - repeated exposure: Based on available data, the classication criteria are not met.
Aspiration hazard: Not likely, due to the form of the product.
Chronic eects: Prolonged exposure may cause chronic eects.
Section 12: ECOLOGICAL INFORMATION
Ecotoxicity: Toxic to aquatic life with long lasting eects.
COMPONENTS SPECIES TEST RESULTS
Distillates Petroleum Hydrotreated Light (CAS 64742-47-8)
Aquatic
Fish LC50 Rainbow trout,donaldson trout
(Oncorhynchus mykiss)
2.9 mg/l, 96 hours
d-limonene (CAS 5989-27-5)
Aquatic
Crustacea EC50
Fish LC50
Water ea (Daphnia pulex)
Fathead minnow (Pimephales promelas)
69.6 mg/l, 48 hours
0.619 - 0.796 mg/l, 96 hours
Persistence and degradability: Not inherently biodegradable.
Bioaccumulative potential: No data available.
Partition coecient n-octanol / water (log Kow): d-limonene 4.232.
Mobility in soil: Readily absorbed into soil.
Other adverse eects: None known.
SAFETY DATA SHEET