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 6.68 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
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: 5.3 ounces (150 grams)
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 Fully discharged battery pack charges
Performance: 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 (2006/A2:2021)."
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.
(2015/A1:2021)."
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 131033 Disposable Barrier Bags – box of 150
P/N 132001 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
Phone: 203-778-0200
Fax: 203-792-2275
Email: info@addent.com
Website: www.addent.com
EMERGO EUROP E
Westervoortsedijk 60,
6827 AT Arnhem
The Netherlands
HEAT DISPENSER
Contents of package: (1) Compex HD unit, (1) wall plug-in USB power supply,
(1) USB charging cord, (25) sample disposable barrier bags, (5) silicone
sleeves, and (1) Instructions for Use.
PRECAUTIONS
!
Not Sterile –
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.
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:
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 13485 COMPLIANT
COMPEX HD INSTRUCTIONS FOR USE
MADE IN THE USA
The silicone sleeves are patient contact parts and
Do not soak the
The battery pack contains rechargeable