Owandy Radiology OWANDY-CAM HD User manual

USER’S MANUAL
EN •NOCMEN010A •03/2021

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Owandy-Cam HD • User’s manual 1
Contents
11
22
33
44
55
66
77
88
99
1010
FOREWORD.................................................................................................. 2
CAMERA INTRODUCTION . .......................................................................... 3
SAFETY INSTRUCTIONS. ............................................................................. 4
REGULATORY REQUIREMENTS................................................................... 6
INSTALLATION. .......................................................................................... 12
CONNECTING TO A COMPUTER................................................................ 13
DESCRIPTION OF THE CONNECTION BOXES. .......................................... 15
MAINTENANCE.......................................................................................... 17
AFTER-SALES SERVICE............................................................................. 19
TECHNICAL FEATURES. ............................................................................ 22

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FOREWORD
To optimize the use of this device, whilst taking all the necessary precautions, we recommended you read
carefully and follow the owner’s manual.
Please carefully consider the messages “CAUTION”, “WARNING”, and “NOTE” when using the system.
CAUTION: the term CAUTION describes potential incidents likely to jeopardize safety.
!
WARNING: the term WARNING refers to the incidents likely to disturb the smooth running of the imaging
system.
NOTE : the term NOTE highlights particular points in order to facilitate the system maintenance or to
clarify important information.
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CAMERA INTRODUCTION
Congratulations on your purchase of the Owandy-Cam HD.
It is an extra- and intra-oral camera designed for dental applications. It allows the user to see anatomical
and pathological details that cannot be seen with the naked eye, as well as pathology control and post-
treatment.
This fluorescence Imaging device is composed of a handpiece (Owandy-Cam HD) and a connection box (MINI
DOCK USB2) as well as various accessories necessary for it to work.
Owandy-Cam HD
• 1 handpiece integrating the camera electronics and lighting.
• 1 handpiece holder.
• 10 dental barriers.
• USB key of QuickVision software including camera and software user’s manuals.
• A quick start of Owandy-Cam HD
MINI DOCK USB2
• A USB2 connection box with a 2.5 metre connecting cable.
This device has been packaged in a custom carton. This carton should be kept for future possible
transportation. As a complement to the dental camera, we provide some dental barriers necessary for intra-
oral use of dental camera. For more details about these products, please refer to our catalogue or contact
our commercial service.
NOTE :
The device was designed and developed with its accessories in order to guarantee to you safety and performance
maximum. The use of different origin accessories can represent a risk for you, your patients and your device.
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SAFETY INSTRUCTIONS
• DO NOT expose the camera to water spray and do not store it in a humid environment (to prevent risk of
electrocution).
• When handling camera and dental barriers, always take the appropriate hygiene measures and precautions
in order to prevent cross contamination risks.
• Infection control procedures must be observed when using accessories such as dental barriers. When
using accessories always follow the manufacturer’s instructions on how to use said accessory and prevent
cross contamination risk from one patient to another.
• Install the camera in a clean, dry, and well-ventilated place.
• Disconnect the connection box from the power supply if you are not going to use it for several days. Do not
pull on the cable.
• DO NOT compress or nip the handpiece cable.
• DO NOT expose the product to high vibrations.
• DO NOT drop the handpiece.
• Handpiece should NEVER be immersed in any liquid, NOR should it be autoclaved.
• For each new patient, it is essential to use the dental barriers provided with the handpiece. Before using
the camera, make sure it does not have any sharp edges.
• The surface temperature in the light emission area can reach above 41°C (after several minutes of use).
Therefore avoid maintaining this emission area in contact with the patient’s mouth.
• The camera is a product using group 1 LEDs according to IEC 62471. To avoid any ocular risk do not look
directly at the light.
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NOTE :
If the hygienic protection is torn while examining a patient or if the handpiece was “infected” while withdrawing
the hygienic protector, it is essential to totally disinfect the handpiece. In order to do this: please refer to the
maintenance chapter.
CAUTION:
Modication of the product, without the permission of the manufacturer, is prohibited.
CAUTION:
If the medical equipment is changed, an appropriate control and test should be performed to ensure that the
medical equipment still can be used safety.

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REGULATORY REQUIREMENTS
4.1. COMPLIANCE WITH STANDARDS AND REGULATIONS
This product was designed and manufactured by a company having an authorized quality system. It meets
the European directive 93/42/EEC requirements relative to medical devices. Therefore, it particularly meets
electrical safety and electromagnetic compatibility standards (IEC) (CEM).
4.2. ELECTROMAGNETIC INTERFERENCE AND ELECTROSTATIC DISCHARGES
Electromagnetic compatibility (CEM) is the ability of electronic device elements to correctly interact in an
electronic environment. Although the Owandy-Cam HD system was designed according to this compatibility
and complies with the electromagnetic interference thresholds established by the regulatory agency,
there is no guarantee about interference likely to occur on a particular installation. If the device generates
interference with radio communication services (which can be determined by switching it off and on), it is
recommended to try to correct this phenomenon by taking whole or part of the following measures:
• Change the receiving antenna orientation
• Reposition the product according to the receiver.
• Take the computer away from the receiver.
The Owandy-Cam HD camera is designed and tested to be used in a home environment, class B Group 1,
according to CISPR11 standard.
4.3. MEDICAL DEVICE VIGILANCE
As with any medical device, this device is subjected to medical device vigilance dispositions; any serious
dysfunction should then be the subject of a description to the competent authorities and to the manufacturer
as soon as possible and as precisely as possible.
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4.4. END OF LIFE
This device bears the recycling symbol according to the European directive 2002/96/EC about electric and
electronic equipment waste (DEEE or WEEE). By correctly disposing of this device, you will contribute to
avoiding any damage to the environment and human health.
The symbol on the device or on the accompanying documentation indicates this product cannot be, in
any case, treated as household waste. Therefore, it should be transferred to a waste collection centre that
handles electric and electronic equipment recycling. Please respect the standards relative to waste disposal
in force in the installation country. For more details about the device treatment, recuperation and recycling,
please contact your dental device distributor (or failing that, www.owandy.com), so that you can be informed
of the procedure.

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4.5. ELECTROMAGNETIC COMPTABILITY
Guide and declaration of the manufacturer - electromagnetic emissions
Owandy-Cam HD device is intended to be used in the electromagnetic environment specified below.
The user should make sure it is used in this environment.
Emission trial Compliance Electromagnetic environment - Guide
RF emissions
CISPR 11 Group 1
Owandy-Cam HD device only uses radio energy for its
internal functions. Therefore, its RF emissions are very
low and are unlikely to cause interference with nearby
electronic devices.
RF emissions
CISPR 11 Class B
Owandy-Cam HD device may be used in all domestic
environments, including the ones directly connected to
the public low voltage power distribution network used
to supply household buildings.
Harmonic emissions
EN 61000-3-2 Not applicable
Voltage fluctuations /
Flicker
EN 61000-3-3
Applicable

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Guide and declaration of the manufacturer - electromagnetic immunity
Owandy-Cam HD device is intended to be used in the electromagnetic environment specified below.
The user should make sure it is used in this environment.
Immunity trial CEI 60601
Severity level
Compliance
level
Electromagnetic environment
Guide
Electrostatic
discharges
EN 61000-4-2
± 6 kV when in contact
± 8 kV in the air
± 6 kV
± 8 kV
The floor should be wooden, concrete or tile. If the floor
is covered with a synthetic material, the relative humidity
should be at least 30%.
Far transient bursts
EN 61000-4-4
± 2 kV for the feed cables
± 1 kV for the input/output
cables
± 2 kV
± 1 kV
The main power supply quality should be one of a
traditional commercial or hospital environment.
Voltage shocks
EN 61000-4-5
Differential mode ± 1 kV
Common mode ± 2 kV
± 1 kV
N.A.
The main power supply quality should be one of a
traditional commercial or hospital environment.
Dips, brief outages and
power voltage variation
EN 61000-4-11
• <5% Ut - for 10 ms
• 40% Ut - for 100 ms
• 70% Ut - for 500 ms
• <5% Ut - for 5 s
<5% Ut 10 ms
<40% Ut 100 ms
<70% Ut 500 ms
<5% Ut 5 s
The main power supply quality should be one of a
traditional commercial or hospital environment.
If the user of Owandy-Cam HD device requires it to
continue to operate during main power supply outages,
it is recommended Owandy-Cam HD device is fed by an
inverter or a battery.
Magnetic field with the
network frequency
(50/60 Hz)
3 A/m 3 A/m
The magnetic field with the network frequency should
be at a characteristic level of a location in a traditional
commercial or hospital environment.
Note: Ut is the power voltage nominal value applied during the trial.

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Guide and declaration of the manufacturer - electromagnetic immunity
Owandy-Cam HD device is intended to be used in the electromagnetic environment specified below.
The user should make sure it is used in this environment.
Immunity trial CEI 60601
Severity level
Compliance
level
Electromagnetic environment
Guide
Conducted RF
EN 61000-4-6
Radiated RF
EN 61000-4-3
3 Vrms
150 kHz to 80 MHz
3 V/m
80 MHz to 2,5 GHz
3V
3V/m
Portable and mobile RF communication devices should not
be used at a distance from Owandy-Cam HD device including
the cables, lower than the recommended separation distance,
calculated with the applicable formulas depending on the
emitter frequency.
Recommended separation distance
d = 1.16√P
d = 1.16√P 80 MHz to 800 MHz
d = 2.33√P 800 MHz to 2.5 GHz
where is the maximum rated output of the transmitter
in watts (W) by the transmitter manufacturer and d the
recommended separation distance in metres (m).
The field levels emitted by the fixed RF transmitters,
determined by an electromagnetic measurement of the sitea,
should be lower than the compliance level in each frequency
band b.
Interference may occur in the vicinity of the devices bearing
the following symbol:
Note 1 : At 80 MHz and 800 MHz, the higher frequency band applies.
Note 2 : These recommendations may not apply in every situation. Electromagnetic wave propagation is modified by the
absorption and reflection due to the structures, objects and persons.

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a The fixed transmitter field levels, such as the base stations of the radio telephones (cellular/wireless) and the terrestrial mobile
radios, domestic radio, AM, FM, and TV radio communication cannot be theoretically assessed precisely. To obtain the electroma-
gnetic environment due to the fixed RF transmitters, a site measurement should be performed. If a field level measured in the use
environment of Owandy-Cam HD device exceeds the compliance levels above applicable, the good operation of Owandy-Cam HD
device should be checked. If abnormal operations are proved, some further measures should be taken, such as reorientation or
relocation of the standard device.
b Above the 150 kHz to 80 MHz frequency band, the field level should be lower than 3 V/m.
Recommended separation distances between the portable and mobile RF communication devices
and Owandy-Cam HD device
Owandy-Cam HD device is intended to be used in an electromagnetic environment in which the irradiated RF disturbances are
checked. The user of Owandy-Cam HD device can help to avoid electromagnetic interference by maintaining a minimal distance
between the portable and mobile RF communication devices (transmitters) and the recommended Owandy-Cam HD device such as
recommended below, depending on the maximum output power of the communication device.
Rated maximal output
power of the transmitter
W
Separation distance depending on the transmitter frequency - m
150 kHz to 80 MHz 80 MHz to 800 MHz 800 MHz to 2,5 GHz
d = 1.6 √P d = 1.6 √P d = 2.33 √P
0.001 0.116 0.116 0.233
0.1 0.366 0.366 0.736
1 0.16 1.16 2.33
10 3.66 3.66 7.36
100 11.6 11.6 23.3
For the transmitters whose maximal output is not listed above, the recommended separation distance d in metres (m) can be determined
by using the equation applicable to the transmitter frequency, where P is the maximal output of the transmitter in watts (W) rated by
the transmitter manufacturer.
Note 1 : At 80 MHz and at 800 MHz, the separation distance given in the higher frequency band applies.
Note 2 : These recommendations may not apply in every situation. The electromagnetic wave propagation is modified by absorption and reflection due
to the structures, objects and persons.

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INSTALLATION
The device is intended to be used by a dental practitioner. Its installation does not require any special training.
Consult the instructions in this manual.
5.1. CONNECTING
Fastening the handpiece holder:
1. Choose a plain area that can be easily accessible for use.
2. Use the wipe provided to clean the surface on which you are going to fasten the holder.
3. Remove the double-sided adhesive tape protection that is on the support, place it, and then press it into
place several times. The maximum sticking performances are obtained after two hours,so avoid any stress
on the holder during this two hour period.
!
CAUTION :
This holder is equipped with magnets that can damage devices sensitive to magnetic elds. Make sure you do not
install this holder near these devices (cathode ray tube video screen, magnetic videotapes, etc.)
5.2 FURTHER CONNECTION BOXES (optional)
You can install a connection box near each dental chair (no limitation). You will just have to transport the
handpiece from one chair to the other.
The handpiece holder is intended to maintain the connecting cable connector when the cable is not linked
to the handpiece.
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CONNECTING TO A COMPUTER
6.1. REQUIRED CONFIGURATION FOR THE COMPUTER
To use the Owandy-Cam HD device, you must make sure the computer and its peripherals do not have any
usage limitation that could concern personal safety. It should also meet the following requirements:
Windows® configuration:
Minimal Configuration Recommended Configuration
Operating system Windows®7 SP1 Windows®10
Processor Intel®Core 2 duo – 3 GHz Intel®Core i5
Memory 2 Go 4 Go or more
Hard disk 250 Go 1 To or more
USB ports 4 ports USB2.0 Hi-Speed 4 ports USB2.0 Hi-Speed
Video board 512 Mo unshared RAM
Compatible with DirectX 9 Chipset Nvidia or ATI / 2 Go of unshared RAM. Memory compatible
with DirectX 9 or higher
USB Chipset Intel or NEC®/ RENESAS® Intel or NEC®/ RENESAS®
Screen resolution 1 280 x 1 024 1 280 x 1 024 or better
MAC® configuration:
Minimal Configuration Recommended Configuration
Computer MacBook®Pro 13.3’’ or iMac®21.5’’ iMac®27’’
Operating system MacOS®X Mavericks MacOS®X El Capitan
Processor Intel®Core 2 duo Intel®Core i7
Memory 2 Go 4 Go
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6.2. MINI DOCK USB2 CONNECTION
• Connect the USB cable to one of the computer USB ports.
• Connect the connecting cable to the handpiece.
6.3. IMAGING SOFTWARE INSTALLATION
Refer to the QuickVision user manual located on the USB key in the « Document » directory.
6.4. IMAGING SOFTWARE CONFIGURATION WITH THE CAMERA
Refer to the QuickVision user manual located on the USB key in the « Document » directory.

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DESCRIPTION OF THE CONNECTION
BOXES
CAUTION:
Devices that connect to the inputs / outputs must be conformed to IEC 60950-1 standard.
7.1. MINI DOCK USB2 POWER SUPPLY
The dental camera electrical supply is directly performed through the computer USB port. The voltage
powering the camera is of continuous 5 V low voltage type (0.5 A).
7.2. USB OUTPUT
This camera has a has a digital USB 2.0 output that can be connected to a computer USB2 port.
7.3. IDENTIFICATION
The indications born on the boxes identify the Owandy-Cam HD device according to the international
standards IEC 60601-1, IEC 60601-2-18 and IEC 60417.
Class II power supply not grounded.
Dental barriers for single use.
Handpiece connection.
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Footswitch connection.
Continuous voltage.
USB2 output.
“BF type camera”.
Follow instructions for use.
Disposal of electric and electronic equipment marketed after 13/August/2005.
This symbol indicates that the product cannot be treated with domestic waste.
For medical devices, this symbol is associated to the manufacturing year
(expressed with four digits).
For medical devices, this symbol is associated to the manufacturer name and address.
Product compliance according to the European directive 93/42/EEC relative to medical devices.
Electronic user instructions.
The devices that connect to USB outputs should comply with IEC 60950 standard.

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MAINTENANCE
The camera Owandy-Cam HD does not need any maintenance if it is used according to the manufacturer’s
use and cleaning instructions.
Before first using it, it is imperative to follow the complete disinfecting procedure.
Any camera returned from servicing or maintenance should be completely disinfected before being used.
!
WARNING:
Do not use products containing:
• Ammoniac, trichloroethylene
• Dichloroethylene
• Ammonium hydrochlorid
• Chlorinated and aromatic hydrocarbon
• Ethylene dichloride
• Methylene chloride
• Ketones
Use of these chemicals subject plastic parts to risk of deterioration.
!
WARNING:
Do not directly spray disinfecting products on Owandy-Cam HD products.
!
WARNING:
Infection control procedures must be observed when using accessories such as dental barriers in order to prevent
cross contamination risk from one patient to another.

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8.1. HANDPIECE OR CONNECTION BOX MAINTENANCE
NOTE:
In case of contact with blood or excessive soiling, it is strongly recommended to follow a disinfecting process. First
of all, clean the handpiece with disinfecting wipes, then wrap the handpiece in several disinfecting wipes and leave
for 15 minutes.
DESCRIPTION RECOMMENDATIONS
USE INSTRUCTIONS AND PRECAUTIONS
 
Disinfecting Surface cleaning and
disinfecting wipes
9Take the wipe, remove
excess moisture, and
then wipe the equip-
ment until visible clean-
liness is obtained.
9Allow to dry in the open
air.
9Carefully close the pac-
kaging box.
8Do not scrub
8Do not rinse.
8Do not immerse
in a disinfecting
liquid.

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AFTER-SALES SERVICE
9.1. WARRANTIES
OWANDY RADIOLOGY ensures its products to be free from material and manufacturing defects for a period of two (2)
years from the date of purchase, with 5 years warranty extension in option. This warranty does not apply to misused,
modified, untended, or accidentally damaged products, or products subject to abnormal use and handling conditions.
The distributors, other than OWANDY RADIOLOGY subsidiaries, are not authorized to apply an extended warranty period
on behalf of OWANDY RADIOLOGY.
The entire liability of OWANDY RADIOLOGY is limited to its convenience when replacing or repairing, free of charge the
defective product, if it has been sent to OWANDY RADIOLOGY After-Sales Service. This applies for the warranty period.
Outside of France, access to the warranty is only possible if the product was bought at a point of sale by an authorized
OWANDY RADIOLOGY dealer in the country where it will be used.
THIS WARRANTY APPLIES ONLY TO THIS UNIQUE REMEDY. IT REPLACES ANY OTHER WARRANTY, FOR EXAMPLE,
A WARRANTY OF ADEQUACY TO A PARTICULAR AIM, SHOULD IT BE EXPLICIT OR IMPLICIT. OWANDY RADIOLOGY
SHALL NOT BE LIABLE FOR ANY PARTICULAR DAMAGE, INDIRECT, ACCIDENTAL OR CONSEQUENTIAL NOR FOR ANY
DETERIORATION OR DATA LOSS, ON A CONTRACTUAL, NON-CONTRACTUAL OR OTHER BASIS.
The liability exclusion or limitation for direct or indirect damages does not apply under the regulatory or legal rules in
force in some countries and the present exclusion may not apply to a purchaser in those countries.