AdDent Compex HD User manual

COMPEX HD INSTRUCTIONS FOR USE
MADE IN THE USA
P/N 660202 REV. A 2021/10
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ISO CERTIFIED
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HEATED DISPENSER
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Contents of package: (1) Compex HD unit, (1) wall plug-in USB power
supply, (1) USB charging cord, (25) sample disposable barrier bags, (10)
silicone sleeves, and (1) Instructions for Use.
PRECAUTIONS
Not Sterile – The silicone sleeves are patient contact parts and
are provided in a non-sterile condition. They must be sterilized
prior to initial patient contact and between patient applications. Refer to
instructions for a) Cleaning and b) Sterilizing the silicone sleeve.
The Compex unit can be disinfected to prevent cross
contamination. The plastic housing should only be wiped with a
cloth and disinfectant. Do not spray the plastic housing. Refer to
instructions for c) Disinfecting the Compex HD housing.
DO NOT AUTOCLAVE THE COMPEX UNIT. Do not soak the
Compex unit in disinfectant solution. The Compex contains
sensitive electronic components.
Before heating and expressing composite, ensure that the compule
(PLT) is fully seated in the compule holder by inserting compule
with even rm pressure.
Attempting to express composite that has not been warmed to
operating temperature may result in damage to the unit.
Battery Disposal: The battery pack contains rechargeable Lithium
Ion batteries (Li-Ion). Recycle or dispose of battery pack according
to national, state, and local regulations.
INTENDED USE
The Compex HD unit is intended to be used by a dentist or health care
provider to warm and dispense dental composite materials contained in a
compule or PLT (Pre-Loaded Tip) to 155 F (68 C).
COMPULES THAT FIT THE COMPEX DISPENSER
The Compex was designed to t most compules on the market with a
diameter of 6.32 mm to 6.55 mm. Please see our website for a
comprehensive list. (www.addent.com)
After continuous use of larger diameter compules, check to ensure
that smaller diameter compules have a secure t in the compule
holder prior to use.
PRODUCT SPECIFICATIONS
Compex Measurements: Unit Length: 5.75 inches (145 mm)
Unit Height: 5.2 inches (130 mm)
Unit Width: 1.2 inches (27 mm)
Unit Weight: 8.1 ounces (230 grams)
includes battery charger
AC Supply Connection: 100-240 Volts AC ± 10%, 50/60 Hz.
USB Power Supply: 5 VDC, 2A
Battery Specication: Li-Ion single cell battery pack with safety circuit
Output: 3.6V, 3350mAh
Type: Lithium Ion.
Performance: Approximately 100 applications
starting with 100% charge.
Battery Pack life: 500 full recharge cycles,
approximately 5 years worth of use.
Safety: Batteries are protected from over
charging, over discharging and short circuiting
by means of a built-in safety circuit.
Charging Circuit Performance: Fully discharged battery pack charges
to 100% in approximately 4.5 hours.
Smart charging circuit provides correct
voltage and current characteristics for
charging battery pack: Constant current
then constant voltage, 3.6 Volts,1.2A, @ 20°C.
Safety: This device complies with ANSI/AAMI/IEC
60601-1, “Medical Electrical Equipment – Part
1: General Requirements for Basic Safety and
Essential Performance (Third Edition,
Amendment 1 2012).”
EMC: This device complies with ANSI/AAMI/IEC
60601-1-2, “Medical Electrical Equipment,
Part 1-2: General Requirements for Basic
Safety and Essential Performance –
Collateral Standard: Electromagnetic
Disturbances – Requirements and Tests, 4th
Ed. (2014).”
WARRANTY
AdDent, Inc. hereby warranties that for a period of one year from date of
purchase; this instrument shall be free from defects in materials and
workmanship and will perform satisfactorily under normal use.
ACCESSORIES AND REPLACEMENT PARTS
P/N 131031 Disposable Barrier Bags – box of 150
P/N 131032 Autoclavable Silicone Sleeves – box of 10
P/N 130002 Medical grade power supply
REPORTING OBLIGATION
Any event such as death or serious injury that has occurred to the patient,
user or other persons in relation to use of this device should be reported to
AdDent, Inc. and the competent authority of the Member State in which the
user and/or patient is established.
PATENTS
This product is covered by one or more of the following patents with other
patents pending: 6,312,254 • 6,616,448 • 7,097,452 • 10,172,690 •
10,548,688 • EP1190681
Patents Insured By IPISC
MANUFACTURER
AdDent, Inc.
43 Miry Brook Road, Danbury CT 06810 USA
Phone: [phone]
Fax: [phone]
Email: [email protected]
Website: www.addent.com

Heating additional compules:
3. Do not turn the unit o󰀨.
4. Remove the rst compule.
5. Install a new compule and immediately turn the unit o󰀨 and then
back on.
6. Allow the compule to heat for one minute. At one minute the temperature
status LED will turn from blinking AMBER to blinking GREEN and the
composite is warm and ready to express.
7. Additional compules can be heated by repeating steps 3 through 6.
Optional: Save time by pre-heating additional compules using the
AdDent Calset Composite Warmer.
1. Set the Calset Composite Warmer on the high temperature setting 155°F
(68°C) and allow it to reach operating temperature (20 minutes for small
trays, 30 minutes for large trays).
2. Place the desired number of compules in the Calset Tray and allow
su󰀩cient heating time, approximately three minutes.
3. Do not turn the Compex unit o󰀨.
4. Remove the rst compule.
5. Install a pre-heated compule in the Compex. The composite is ready to
express immediately.
6. Additional compules can be heated by repeating steps 3 through 5.
•Note - We suggest you try shorter and longer heating cycles to determine
the optimum heating time for the composite you are using prior to clinical
application.
• Once the heating cycle has been activated, pressing the on/o󰀨 button again
will shut o󰀨 the unit and switch it back into sleep mode.
• The auto shut o󰀨 feature takes place after 10 minutes of ON time to
conserve battery power.
•Tip: Avoid touching the compule ejector to the patient while dispensing
material to avoid accidently ejecting the compule.
• Tip: To conserve battery power, turn o󰀨 dispenser after procedure is
complete.
Caution: To avoid damage to the unit, always remove compule after
procedure is complete. Do not store the Compex HD unit with
compule installed in the compule holder.
COMPULE HEAT UP TIME
• The Compex will heat the composite from 72°F (22°C), room temperature,
to 155°F (68°C) in approximately 2 minutes.
REMOVING THE COMPULE
Caution. Some compules can forcefully eject during the removal
process. Be sure to hold your hand below the compule to catch it
when it comes out.
• To remove the compule, press down on the raised portion of the compule
ejector. This feature allows the rear of most compules to tilt down for easy
removal.
CLEANING/DISINFECTING/STERILIZING
a) Cleaning the silicone sleeve:
CHARGING THE UNIT
Note: The Compex HD unit should be fully charged prior to rst time use.
A wall plug-in USB power supply is provided to charge the unit. The power
supply operates from wall Voltages from 100 to 240 Volts, AC. Connect the
USB cord to the power supply and plug the power supply into a suitable wall
outlet. Plug the opposite end of the USB cord into the connector located on
the bottom of the Compex HD handle.
Do not attempt to use the Compex HD when the unit is
charging. The unit cannot be activated while the power supply
is connected to the unit.
BATTERY CHARGE INDICATOR
Charging the Compex HD: While charging the unit, the right side
LED battery charge indicator blinks red. When the unit is fully
charged, the LED turns solid green.
Operating the Compex HD: While using the unit, the right side LED battery
charge indicator operates as follows:
GREEN - Battery is charged, normal operation.
AMBER - Battery charge at approximately 20%, unit has 10 minutes of
useful charge remaining.
RED - Battery is at the end of useful charge and requires recharging.
TEMPERATURE STATUS INDICATOR
The LED on the left side indicates the temperature status. For the
rst minute of the heating cycle the temperature status LED blinks
AMBER. At one minute the LED starts blinking GREEN. At two
minutes the LED turns solid GREEN. The LED stays solid GREEN for the
remaining eight minutes of the heating cycle.
INSTALLING THE COMPULE (PLT)
1. Place the compule into the opening in the barrel ensuring that the
compule ange is positioned as far back as possible.
2. Press the compule into the compule holder with rm even pressure. The
compule will snap into place.
3. Ensure that the compule body is fully seated against the compule holder
with the compule ange as far back as possible.
OPERATION – HEATING AND DISPENSING COMPULES
• The heating cycle warms the composite to 155°F (68°C): Pressing the
on/o󰀨 button once activates the heating cycle. For the rst minute of the
heating cycle the temperature status LED blinks AMBER. At one minute the
LED starts blinking GREEN. At two minutes the LED turns solid GREEN.
The LED stays solid GREEN for the remaining eight minutes of the heating
cycle.
Heating one compule:
1. Install a compule and press the on/o󰀨 button once.
2. Allow the compule to heat for two minutes. At two minutes the
temperature status LED will turn solid GREEN and the composite is warm
and ready to express.
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• Immerse/thoroughly drench parts in a surface decontaminate cleaner
(soap and water cleaning solution).
• After 10 minutes, scrub with an instrument cleaning brush until visibly free
from debris.
• Rinse all parts with warm water.
b) Sterilizing the silicone sleeve:
• Sterilize in a steam autoclave using distilled water at a temperature of
270°F (132°C) for 20 minutes.
• Do not add chemical solutions to the autoclave.
• Do not use a chemical autoclave.
c) Disinfecting: The Compex HD housing can be disinfected following these
guidelines:
• Wipe all surfaces with a disinfectant comprising 72% - 55% alcohol and
.33% -.5% quaternary ammonium and follow the manufacturer’s directions.
Some popular disinfectant wipes in this category are:
1 - Monarch Surface Disinfectant Wipes (Air Techniques)
2 - Opticide 3 Wipes (Biotrol)
3 - Super Sani-Cloth Wipes (PDI)
• Wipe, do not spray, solution onto the Compex HD housing. Prevent liquids
from entering openings on unit.
Do not autoclave the Compex HD unit. Doing so will damage the
unit and invalidate the warranty.
In order to protect this device and help prevent cross contamination we have
developed a disposable barrier bag and an autoclavable silicone sleeve.
TROUBLESHOOTING GUIDE
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Problem
1. Battery not charging
2. Trigger sticking after
expressing composite
material.
3. Compule not heating
4. Compule not heating
- left side LED heat
indicator turns RED for
ve seconds then turns
o󰀨.
C a u s e
a. USB Charging cable
connection
b. No power to the USB
Power Supply.
c. Battery at end of life
Composite
accumulated on
plunger tip
a. Composite material
accumulated on heating
element.
b. Battery discharged
(battery indicator red or
unit will not turn on)
c. Unit has turned o󰀨
after 10 minutes.
Faulty temperature
sensor
Solution
a. Ensure USB charging
cable is securely
connected to USB
power supply and to the
Compex HD unit.
b. Ensure there is power
at the USB power supply.
c. Replace the battery
Squeeze trigger to
expose plunger tip and
use soft cloth or Q-tip
to remove accumulated
composite material.
a. Use soft cloth or Q-tip
to remove accumulated
composite material.
b. Charge battery
c. Restart heating cycle
Return unit for repair.