AdDent Compex HD Instructions For Use

COMPULES THAT FIT THE COMPEX DISPENSER
The Compex was designed to fit 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 fit in the compule
holder prior to use.
PRODUCT SPECIFICATIONS
Unit Length: 5.75 inches (145 mm)
Compex Measurements:
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 Specification: 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,
Amend ment 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: 203-778-0200
Fax: 203-792-2275
Email: info@addent.com
Website: www.addent.com
HEATED DISPENSER
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 firm 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 ).
ISO CERTIFIED
COMPEX HD INSTRUCTIONS FOR USE
MADE IN THE USA