Gendex AcuCam Concept IV FWT User manual

Intraoral Camera
Gendex Dental Systems
901 West Oakton Street
Des Plaines, IL 60018 U.S.A.
Tel [phone]
Fax [phone]
www.gendex.com
Authorized Representative:
KaVo Dental GmbH
Bismarckring 39
88400 Biberach, Germany
www.gendex-dental.com
www.kavo.com
User Manual
Installation Manual

Gendex Dental Systems
901 West Oakton Street
Des Plaines, IL 60018 U.S.A.
Tel [phone]
Fax [phone]
www.gendex.com
Authorized Representative:
KaVo Dental GmbH
Bismarckring 39
88400 Biberach, Germany
www.gendex-dental.com
www.kavo.com
Installation Manual

032-0161-EN Rev 5 -iii
Chapter 1 - Introduction
Key Features ...............................................................................................................1-1
Incorporating the Camera into the Practice .................................................................1-2
System Components ........................................................................................... 1-3
Environmental ............................................................................................................1-3
Conformance ..............................................................................................................1-3
Computer Requirements .............................................................................................1-4
AcuCam Concept IV Handpiece ....................................................................................1-4
The Concept IV FWT Docking Station ...........................................................................1-5
The Concept IV FWT Holster .........................................................................................1-7
Intended Use ...................................................................................................... 1-8
Users .................................................................................................................. 1-8
About This Manual .............................................................................................. 1-8
Service ............................................................................................................... 1-8
Copyright ............................................................................................................ 1-8
Chapter 2 - Safety Items
Important Information ......................................................................................... 2-1
Warnings, Cautions, and Notes ........................................................................... 2-1
Warnings ....................................................................................................................2-2
Cautions .....................................................................................................................2-3
Notes ..........................................................................................................................2-3
Location of Identification Labels ......................................................................... 2-4
System Labels ............................................................................................................2-5
Compliance with Applicable Standards ............................................................... 2-7
Chapter 3 - Installation
Unpacking System Components .......................................................................... 3-1
System Components ...................................................................................................3-2
Equipment Positioning Considerations ................................................................ 3-2
Docking Station Installation ................................................................................ 3-3
Remove the Concept IV FWT Cover ...............................................................................3-4
Release the Mounting Bracket ....................................................................................3-4
Table of Contents

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Mount the Wall Brackets .............................................................................................3-5
Re-Attach the Docking Station Chassis .......................................................................3-5
Wire the Docking Station ............................................................................................3-5
Mount the Cabinet Brackets ........................................................................................3-6
Holster Installation .....................................................................................................3-8
Wiring the AcumCam Concept IV FWT System ............................................................3-10
Loading the AcuCam Concept IV FWT Software Driver ................................................3-11
Moving, Storage, and Shipping ......................................................................... 3-11
Support Equipment and Supplies ...................................................................... 3-12
Consumables/Software ............................................................................................3-12
Hardware ..................................................................................................................3-12
Chapter 4 - System Operation
Attaching/Detaching the Camera to the Docking Station ..................................... 4-1
To Attach the Camera: .................................................................................................4-1
To Detach the Camera: ................................................................................................4-1
Turning on the System ........................................................................................ 4-2
Holding the Handpiece ........................................................................................ 4-2
Focusing the handpiece ...................................................................................... 4-3
Controlling the Lamp Power ................................................................................ 4-5
Using the Alternative Input Channel .................................................................... 4-5
Using the Footswitch ........................................................................................... 4-6
Using the Software ............................................................................................. 4-6
Live Video Stream .......................................................................................................4-6
Icon and Menu ............................................................................................................4-7
Chapter 5 - Maintenance
Replacing the Camera Lamp ........................................................................................5-1
Cleaning and Infection Control ............................................................................ 5-3
Barrier Method ...........................................................................................................5-3
Installing Sheaths ......................................................................................................5-4
Heat Sterilization ........................................................................................................5-6
Use of Disinfectants/Cleaners .....................................................................................5-6
Cleaning the Camera Sapphire Window .......................................................................5-7
Cleaning the Docking Station ......................................................................................5-8
Chapter 6 - System Specifications
Camera (Handpiece) ............................................................................................ 6-1
Docking Station .................................................................................................. 6-2
Power Supply ...................................................................................................... 6-2

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Chapter 7 - Compliance with Applicable Standards
Appendix A - Gendex Limited Warranty

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032-0161-EN Rev 5 1-1
Chapter
1Introduction
The AcuCam® Concept® IV FWT intraoral camera system is the latest addition to the Concept IV
product line. This product provides the best digital image quality and simplest installation and
operation with a computer by eliminating the need for a video capture board. Video is
transmitted losslessly directly to your imaging software. The AcuCam Concept IV FWT provides
the conveniences of digital imaging with the same brilliant high-resolution images of the
Concept IV for analog environments. The AcuCam Concept IV FWT shares the same great camera
handpiece design with the Concept IV, but now takes the image directly to the computer via a
digital connection. The docking station generates a truly uncompressed digital live video output
according to the IEEE1394a standard (also known as FireWire or i.LINK). The AcuCam Concept IV
FWT also provides an analog output signal for video monitors.
Key Features
•Ergonomically designed handpiece with slim distal end for complete
intraoral access.
•State-of-the-art optical system with an adjustable focus range of 1
mm to infinity.
•A new level of portability with the CCU integrated into the camera
head, and a lightweight camera cable.
•A compact versatile docking station, with a small footprint, that
output digitally directly to a computer system through the fast
FireWire or i.LINK connection (IEEE1394a).
•Easily transportable between operatories, thanks to the “Hot Plug”
connection, always ready to use.
•Modern looking docking station with wall mount, flush mount,
under- or on-counter top configurations.
•Additional analog output for analog video networks and analog
displays.
•Additional analog input for alternative video source.

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Incorporating the Camera into the Practice
The AcuCam Concept IV FWT Intraoral Camera System makes it easy for you
and your staff to engage your patients in their own oral health. Practitioner
and patient together can ‘walk through’ the patient’s oral exam and discuss
what they discover. Instantaneous, high-resolution video imagery makes the
patient a participant in the examination process. AcuCam Concept IV FWT
helps you to achieve a high degree of patient interaction that is unattainable
without this technology.
NOTE: Gendex understands that examination protocol is a highly
individualized matter. This information is presented as an example of
one possible protocol.
Begin with the upper or lower rear molar. Show the distal surface, then the
buccal, then rotate the handpiece camera to show the occlusal, and finish
with the lingual. Continue the examination from posterior to anterior. For best
use results, it is important to rest the camera on a fulcrum point, such as an
arch, and angle the camera. This procedure reduces jitter and facilitates
focusing.
The illumination and magnification of the intraoral image on the monitor
allows greater observation of the condition of the patient’s mouth. Typically,
the patient will be observing the examination along with you and may ask
questions.
If you discover something positive, such as a particularly attractive anterior
crown, onlay or veneer, mention it as an example of superior restorative
dentistry. This will help to build patient confidence. Conversely, if you discover
something negative, such as evidence of periodontal disease, report this also.
When you have completed the intraoral portion of the video examination, use
the extraoral setting to capture full smile and full-face views.

Introduction
032-0161-EN Rev 5 1-3
System Components
Environmental
Conformance
CAUTION
System installation shall be in accordance with the requirements of IEC
60601-1-1, The Standard for Safety Requirements of Medical Electrical
Systems.
Patients should only be connected to applied parts of equipment complying
with IEC 60601-1. Other equipment used in the system should comply with
relevant IEC or ISO Standards.
U.S. Gov’t Classification -
Ingress Protection
IPXO
U.S. Gov’t Classification -
Console and Power Supply
Medical Grade
Classification - Handpiece Cabled camera head, Medical Grade Type BF
Environmental conditions for
transportation and storage
-25°C — 70°C
Relative humidity range 10% — 100%
Atmospheric pressure range 500 hPa — 1060 hPa
Environmental conditions for
operation
+10°C — 40°C
Evaluated to meet the Requirements of the Medical Device Directive (MDD) as a Class 1
Device, UL 60601-1, IEC/EN 60601-1, and CAN/CSA C22.2 No.601.1.
Immunity testing was performed according to IEC 60601-1-2, Electromagnetic
Compatibility
Suitable for continuous
operation
Yes
FDA/21 CFR 820 Class 1

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Computer Requirements
NOTE: “Minimum Requirements” are necessary to obtain a good live video stream in a
window a quarter-of -screen big, while the “Recommended Requirements” are
necessary to obtain a fluent live video stream without any “jittering” effect in full-
screen mode.
Processor Speed Requirements are higher if a laptop PC is being used. For the best
performance with laptops, please make sure that the PC power supply is
connected when the Concept IV FWT is streaming video.
AcuCam Concept IV Handpiece
The AcuCam Concept IV camera handpiece is a sophisticated dental instrument
designed to provide the highest quality intraoral and extraoral images. The
Concept IV camera integrates the latest in video electronics and an advanced
Minimum System
Requirements
Recommended System
Requirements
Operating
System
Microsoft®
Windows®
XP-PRO
Microsoft®
Windows® Vista
Business
Microsoft®
Windows®
XP-PRO
Microsoft®
Windows® Vista
Business
Processor 800 MHz
1.3 GHz if a
laptop computer
is used
1 GHz 32-bit 1.3 GHz or higher
1.8+ GHz if a
laptop computer
is used
1.3 GHz dual core
or higher
1.8+ GHz if a
laptop computer
is used
Memory 128 MB 512 MB 256 MB 2GB
Hard Disk 10 GB with 1.5 GB
available
20 GB with 15 GB
available
20 GB with 1.5 GB
available
40 GB with 15 GB
available
Display Setting 1024x768 at 32
bit true color
1024x768 at 32
bit true color
1024x768+ at 32
bit true color
1024x768+ at 32
bit true color
Video Memory 8 MB 128 MB 32+ MB 256 MB
Monitor SVGA with
0.25mm/
0.26mm dot pitch
SVGA with
0.25mm/
0.26mm dot pitch
XGA with
0.25mm/
0.26mm dot pitch
XGA with
0.25mm/
0.26mm dot pitch
Ports FireWire or i.LINK
(IEEE-1394a
standard)
FireWire or i.LINK
(IEEE-1394a
standard)
FireWire or i.LINK
(IEEE-1394a
standard)
FireWire or i.LINK
(IEEE-1394a
standard)
Drivers Microsoft DirectX
9.0b or higher
required
Microsoft DirectX
9.0c or higher
required
Microsoft DirectX
9.0b or higher
required
Microsoft DirectX
9.0c or higher
required

Introduction
032-0161-EN Rev 5 1-5
optical system into a lightweight and portable handpiece. The ergonomically
designed handpiece is the product of 15 years of refinement. Please see the
pictures below to identify the key elements of the handpiece.
The Concept IV FWT Docking Station
The Concept IV FWT Docking Station is the system hub with which the camera
connects to all other components of the system. The Docking Station must be
powered with the Power Supply Unit.
CAUTION
Use the AcuCam Concept IV FWT Power Supply Unit only. Using other generic
power supply products may cause damage.
The Docking Station processes the video stream and transmits it to the computer
system through the FireWire port. The docking station is designed to provide easy
access to all input and output connections. Please see the picture to identify the
key features of the docking station.
Monocoil Cable
Handpiece
Connector
Focus Ring
Camera Head
LIght
Guides
Camera Lens
Window
DIstal End of the
Concept IV
Camera Head

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All the connectors but the handpiece are situated in the backside of the Docking
Station.
NOTE: The docking station is conceived for digital video streaming, therefore
it is intended for use with a computer system, through the FireWire
connection. The analog video output is featured for additional analog
monitor only, or for any analog recording or printing device capable of
S-Video input. The analog video output reproduces the video stream
coming from the handpiece only; it doesn’t reproduce any video
coming from the auxiliary input. The docking station allows freezing
and saving images on the computer by pushing the supplied
footswitch. The docking station doesn’t freeze or save images on or to
any analog device connected to the analog video output.
Connection Type (*) Purpose
S-Video IN (S-Video) S-video signal input for alternative analog video sources.
Holster (8-Pin mini-DIN) Holster connection for controlling the handpiece
activation.
S-Video Out (S-Video) S-video signal output for analog monitor.
Foot Switch (8-Pin mini-DIN) Foot Switch connection for freezing and grabbing images
hands free.
IEEE1394a (FireWire) Digital data output for personal computers equipped with
FireWire port.
Power Supply Power connector. Use Gendex Concept IV FWT power
supply unit ONLY.
(*) In this order: from upper left to lower right.

Introduction
032-0161-EN Rev 5 1-7
The Concept IV FWT Holster
The Holster accommodates the Handpiece while not in use. It can be relocated
near by the Docking Station or far from it, through the appropriate connecting
cable. Two cables, of different length, are supplied. The Holster can be attached to
the Docking Station, to the left or to the right, or it can be mounted beside a
cabinet, connected to the dental chair delivery unit or anywhere nearby the patient
area.
A button on the Holster allows to switch On and Off the Handpiece light source or,
holding the button for two seconds, to select the video source. Two LEDs indicate
the selected video source. The primary video source is the AcuCam Handpiece
(Green LED, right side of the button); the alternative video source is whatever is
connected to the Video-IN input available on the Docking Station Back Panel
(Amber LED, left side of the button).
Meaning of LEDs
GREEN BLINKING The system is powered and in Standby mode.
GREEN ON The AcuCam Handpiece is streaming video.
AMBER ON The system is powered and the alternative video source is
selected.
AMBER BLINKING The system is running the equipment diagnostic.
BOTH BLINKING It happens for a few moments only, when powering up the
system by plugging in the power connector.
BOTH ON Faulty condition (the camera is in programming mode,
used during the production phase only).
Holster
Holster
Light
Sensor
Concept IV
Handpiece
Connector
Front Panel
Lamp On/Off Switch
and Video Source Toggle
Video 2 LED -
Amber
(Alternative
Source)
Video 1 LED -
Green
(Concept IV
Camera)

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Intended Use
The AcuCam Concept IV FWT intraoral camera system is a compact, reliable dental
instrument intended for taking intraoral and extraoral images:
1. To assist the dental practitioner in the assessment of the overall dental
health of the patient by providing high quality, magnified images of the
oral cavity which otherwise are difficult or impossible to view.
2. To allow the dental practitioner to provide educational information to the
patient and to more effectively communicate a treatment plan.
3. To provide documented images for patient records, insurance
companies, and health professionals.
4. To allow the practitioner to provide accurate before and after color images
showing the results of the dental procedures performed.
Users
This manual is intended for trained dental professionals and authorized Gendex
Dealer Technical Representatives.
About This Manual
This manual provides essential information necessary for proper installation,
operation, and routine servicing of the AcuCam Concept IV FWT Intraoral Camera
System. If more information is required, please contact Gendex Technical Support.
Service
Any user maintaining or servicing the AcuCam Concept IV FWT unit will void the
warranty.
Gendex strongly recommends that only authorized Gendex dealers maintain and
service the Gendex AcuCam Concept IV FWT Intraoral Camera System.
Copyright
Documentation and the operating software are copyrighted with all rights
reserved. Under the copyright laws, this documentation may not be copied,
photocopied, reproduced, translated, or reduced to any electronic medium or
machine readable form in whole or part, without the prior written permission of
GENDEX Dental Systems. Gendex and AcuCam Concept are registered trademarks
of Gendex.

032-0161-EN Rev 5 2-1
Chapter
2Safety Items
Important Information
It is important that all personnel who intend to operate the AcuCam Concept IV
FWT intraoral camera system read and understand this manual completely
before using the device. Personnel operating the AcuCam Concept IV FWT
system should follow all warnings and cautions outlined below for their safety
and for the safety of those around them. Responsibility for safety when using
the Concept IV FWT Camera System resides with the healthcare professional
using the device. The Concept IV FWT Camera System is safe and effective
when used as described in this manual.
The Concept IV FWT Intraoral Camera System must be installed and serviced
by an authorized service technician, service installer or Gendex
representative.
Warnings, Cautions, and Notes
Before attempting to operate the equipment, it is recommended that you read
this manual thoroughly including all cautions and warnings. This guide uses
the following conventions to describe situations that are potential hazards to
the Patient or Operator, potential loss of data, or potential damage to the
equipment.
WARNING
Warnings are intended to alert the user that failure to follow the procedure
could cause fatal or serious injury to the user, Patient, or any other person, or
result in a misdiagnosis.
CAUTION
Cautions are intended to alert the user that failure to follow the procedure
could cause damage to the equipment or cause loss of data.
ADVISORY: Advisories are used to defined information for the operator
regarding advice towards use of the device or a process.

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NOTE: Notes are used to highlight important or unusual points to be brought
to the attention of the operator.
Warnings
WARNING
For use by trained professionals only. Federal law restricts the sale of this
device except to physicians, dentists, and dental professionals. Use of the
device in procedures other than those described in this manual may result in
injury.
WARNING
Do not open the device to service it. All aspects of the Concept IV FWT system
that are meant to be attended to by the operator are accessible without
opening the internal compartments of the device (metal chassis). If there is a
service problem, please call a qualified dealer service representative or
Gendex Technical Support.
WARNING
Use only grounded electrical connections. Connect the Power Supply unit
(coming with the Concept IV FWT camera system) to grounded electrical
outlets rated for voltage and amperage in accordance with the label ratings on
the product data plate located on the back panel of the Power Supply unit. Use
only Hospital Grade outlets.
WARNING
Hot Surface exposure. The tip of the handpiece connector can temporarily
become hot from the light source. Exercise caution when removing the
handpiece from the docking station and avoid handling the tip-end until the
connector has cooled to the touch.

Safety Items
032-0161-EN Rev 5 2-3
WARNING
Use Only AcuCam Disposable Sheaths. AcuCam disposable sheaths were
designed specifically for the Concept IV handpiece. It is recommended that
only AcuCam sheaths be used in conjunction with the AcuCam handpiece in
order to insure the greatest infection control.
AcuCam Disposable Sheaths are not designed to be reused from patient to
patient. To avoid cross-contamination, place a fresh disposable sheath on the
camera handpiece before use. Used sheaths must be appropriately disposed.
WARNING
Equipment not suitable for use in the presence of a flammable anesthetic
mixture with air or with oxygen or nitrous oxide.
Cautions
CAUTION
Do Not Place Objects on Docking Station. Do not place objects on top of
docking station console. The surface is not flat and objects can slide off
without warning.
CAUTION
Use Care When Handling Cables. Avoid extreme bends in cables or pulling on
cables. Hold the connector housings when connecting or disconnecting
cables.
CAUTION
Do Not Autoclave the Product. Do not autoclave the camera handpiece and
monocoil cable. Autoclaving this component will cause irreparable damage.
Notes
NOTE: Please make sure your computer, imaging software, FireWire port or
capture board are properly installed and operating prior to contacting
Gendex for technical support.

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NOTE: Unlike the fixed focus modes, in Macro view it’s easier to position the
camera first and then adjust the focus ring. Due to the high
magnification, steadying the camera is paramount to obtaining a good
image.
Location of Identification Labels
The AcuCam Concept IV FWT has identification labels that specify the model number, serial
number and applicable product approval listings.
bottom of
unit
back of unit
wrapped
around cord

Safety Items
032-0161-EN Rev 5 2-5
System Labels
Recycle Label: Dispose of in
accordance with your country’s
requirements. There is material in the
system that must be separately
collected and recycled in accordance with the
European Waste Electrical and Electronic
Equipment (WEEE) Directive.
Caution: Consult written instructions
in this Manual.
Medical Equipment with respect to
electric shock, fire, and mechanical
hazards only. In accordance with
UL 60601-1, CAN/CSA-C22.2
No. 60601.1, and IEC 60601-1-2.
The CE symbol ensures that the
product herein specified meets the
applicable provisions of the
European Council Directives.
Class 1, Type BF: Includes Type BF
applied part.
Indicates position of the camera
lamp.

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S-video signal input for alternative
analog video sources.
Holster (8-Pin mini-DIN): Holster
connection for controlling the
handpiece activation.
Model Number/Revision
S-video signal output for analog
monitor.
Foot Switch (8-Pin mini-DIN): Foot
Switch connection for freezing and
grabbing images hands free.
IEEE1394a (FireWire): Digital data
output for personal computers
equipped with FireWire port.
Power Supply: Power connector. Use
Gendex Concept IV FWT power supply
unit ONLY.
Manufactured Date