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 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 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’S
MANUAL
HEATED
GUTTA PERCHA
SYSTEM
1
6
GUIDANCE 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 %
U
T
(>95 % dip in
U
T
) for
0.5 cycle
40 %
U
T
(60 % dip in
U
T
)
for 5 cycles
70 %
U
T
(30 % dip in
U
T
)
for 25 cycles
<5 %
U
T
(>95 % dip in
U
T
) for
5 sec
100 % dip in
U
T
for 0.5 cycle
60 % dip in
U
T
for 5 cycles
30 % dip in
U
T
for 25 cycles
100 % dip in
U
T
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
U
T
is the (AC) mains voltage prior to application of the test level.
