Obtura III MAX User manual

OPERATOR’S MANUAL
Welcome
to the
Your essential guide to our clinically-advanced Heated Gutta Percha System
2260 Wendt Street, Algonquin, IL 60102
[phone] • www.obtura.com
© 2011 Obtura Spartan® 57412G - 10/17/16

Heated Gutta Percha System
The Obtura III MAX is intended to be used by professionally-qualified 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 93/42/EEC and satisfies 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 flammable anesthetics.
Model 823-800 DC 12V, 1.0A
Medical Device Class IIa. 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 Obtura Spartan only.
This equipment contains no electrical parts serviceable by the user.
Environmental Conditions
Symbol
SN/PN
M
+/-
SymbolDescription Description
Ambient Temperature +10ºC to 40ºC -5ºC to +50ºC
Relative Humidity
Attention, see accompanying documents Type BF applied part
Class II Equipment
Use by
Single use, do not re-use
Steam sterilize at temperature indicated
Batch or Lot code Memory preset for temperature
Serial Number/Part Number
Temperature Up/Down
Temperature Up/Down representsthe acceptable
temperature range for transportation of thisdevice.
Allow unit to come to room temperature before use.
Year of Manufacture
Power On/Off
Do not dispose of this equipment as unsorted municipal
waste, it isto be collected separately. Consult local
regulations for disposal.
30% to 75%, non-condensing 30% to 75%
Atmospheric Pressure 860 hPa to 1060 hPa 700 hPa to 1600 hPa
Normal Use Transport and Storage
+48 C
C-17
˚
˚
LOT
NOTES 19
OPERATOR’SMANUAL HEATED GUTTA PERCHA SYSTEM
135
°
C

Quick Start Guide
1. Insert the handpiece cord connector into the handpiece cord port on the rear of the main control unit.
(Follow thecord-label instructions, or you mayfollow the “Handpiece Attachment/Detachment” instructionson page 9)
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 3 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.
Main Power Button
Temperature Buttons
Memory Button
Press and hold this button to turn
the unit on or off.
Use the “+/-“ buttons to change the
temperature by 1 degree.
Press this button to select different
Memory presets.
OPERATOR’SMANUAL HEATED GUTTA PERCHA SYSTEM
Recommended separation distances between portable and mobile RF communications equipment and
the Obtura III Max Heated Gutta Percha System
The Obtura III 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 III 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 III 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 √P80 MHz to 800 MHz d= 1.2 √P80 MHz to 800 MHz d= 2.3 √P
0.01 0.12 0.12 0.23
0.1 0.38 0.38 0.73
1 1.2 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 reflection from structures, objects and people.
18GUIDANCE AND MANUFATURER'S DECLARATION

Table of Contents
Warranty.................................................................................................................................................................1
Safety Information..................................................................................................................................................1
Overview................................................................................................................................................................2
System Description.................................................................................................................................................2
Unpacking and Assembling.....................................................................................................................................3
Operation...............................................................................................................................................................4
Installing a Needle..................................................................................................................................................5
Bending the Needle................................................................................................................................................5
Loading Gutta Percha.............................................................................................................................................5
Expressing Gutta Percha..........................................................................................................................................5
Sterilization Instructions.........................................................................................................................................6
Maintenance...........................................................................................................................................................7
Error Codes..........................................................................................................................................................10
Handpiece Attachment/Detachment......................................................................................................................10
Theory of Operation.............................................................................................................................................10
Frequently Asked Questions..................................................................................................................................11
Factory Repair/Contact Us....................................................................................................................................12
Replacement Parts................................................................................................................................................12
Material Data Safety Sheet....................................................................................................................................13
Manufactured By:
Obtura Spartan
2260 Wendt Street
Algonquin, IL 60102
[phone]
www.obtura.com
Authorized Representative in EEA:
Quality Endodontic Distributors Ltd.
Units 10/12 Orton Enterprise Centre
Bakewell Road, Orton Southgate
Peterborough, PE2 6XU, UK
Tel: [phone]
Fax: [phone]
OPERATOR’SMANUAL HEATED GUTTA PERCHA SYSTEM
Guidance and Manufacturer’s Declaration – Electromagnetic Immunity
The Obtura III Max Heated Gutta Percha System is intended for use in the electromagnetic environment specified
below. The customer or the user of the Obtura III 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
3 Vrms
150 kHz to 80 MHz
3 V/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 dis the recommended separation
distance in meters (m).
Field strength from fixed RF transmitters, as
determined by an electromagnetic site survey, a
should be less than the compliance level in each
frequency range. b
Interference may occur in the vicinity of equipment
marked with the following symbol.
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 reflection from structures, objects and people.
a
Field strengths from fixed 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 fixed RF transmitters, an electromagnetic site survey should be
considered. If the measured field strength in the location in which the Obtura III Max Heated Gutta Percha System is
used exceeds the applicable RF compliance level above, the Obtura III 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 III Max Heated Gutta Percha System.
b
Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.
GUIDANCE AND MANUFACTURER'S DECLARATION 17
EMC Table..........................................................................................................................................................15

TWO-YEAR WARRANTY
Obtura Spartan 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. Obtura Spartan’s 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 fitness 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 fill out the registration card
included in your clear plastic introductory packet.
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 III MAX in the presence of flammable 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 sufficient proximity to the patient so as not to disrupt operation by reaching
too f ar with the handpiece.
6.This Obtura system complies with current Electromagnetic Compatibility standards (IEC 60601-1-2). However,
the usershould 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 15-18).
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 15-18).
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: Obtura Spartan does not assume any responsibility or liability for incorrect diagnosis or failed 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 Obtura Spartan, PN 823-711.
WARRANTY 1
OPERATOR’SMANUAL HEATED GUTTA PERCHA SYSTEM
16GUIDANCE AND MANUFATURER'S DECLARATION
Guidance and Manufacturer’s Declaration – Electromagnetic Immunity
The Obtura III Max Heated Gutta Percha System is intended for use in the electromagnetic environment specified
below. The customer or the user of the Obtura III 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
± 8 kV air
± 2, 4, 6 kV contact
± 2, 4, 6, 8 kV air
Floor should be wood, concrete or
ceramic tile. If floors 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 III Max Heated Gutta Percha
System requires continued
operation during power mains
interruptions, it is recommended that
the Obtura III Max Heated Gutta
Percha System be powered from an
uninterruptible power supply or a
battery.
Power frequency
(50/60 Hz)
magnetic field
IEC 61000-4-8
3 A/m 3 A/m
Power frequency magnetic fields
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.