KaVo DIAGNOcam Vision Full HD User manual

Instructions for use
DIAGNOcam Vision Full HD

Distributed by:
KaVo Dental GmbH
Bismarckring 39
88400 Biberach
Germany
Phone [phone]
Fax [phone]
Manufacturer:
KaVo Dental GmbH
Bismarckring 39
88400 Biberach
Germany
www.kavo.com

Table of contents
1 User instructions ................................................................................................................ 5
1.1 Transport and storage.................................................................................................... 7
1.1.1 Damage in transit .............................................................................................. 7
1.2 Disposal........................................................................................................................ 9
1.2.1 Current packaging law ........................................................................................ 9
1.3 Disposal of electronic and electrical devices ...................................................................... 9
1.4 Terms and conditions of warranty ................................................................................... 10
2 Safety.................................................................................................................................. 11
2.1 Infection hazard ............................................................................................................ 11
2.2 Technical condition ........................................................................................................ 11
2.3 Accessories and combination with other equipment........................................................... 11
2.4 Qualification of personnel ............................................................................................... 12
2.5 Electrical shock.............................................................................................................. 12
2.6 Aspiration and danger of suffocation................................................................................ 12
2.7 Laceration..................................................................................................................... 12
2.8 Electromagnetic fields .................................................................................................... 12
2.9 LED light....................................................................................................................... 13
2.10 Service and repair ......................................................................................................... 13
2.11 Cybersecurity................................................................................................................ 13
3 Product description ............................................................................................................14
3.1 Intended use................................................................................................................. 15
3.2 Symbols on product and rating plate ............................................................................... 16
3.3 Product configurations.................................................................................................... 17
3.4 Technical Specifications.................................................................................................. 17
3.5 Scope of delivery........................................................................................................... 19
3.6 System components ...................................................................................................... 20
3.7 Control panel ................................................................................................................ 21
4 Installation of the wall mount............................................................................................22
5 Startup and shut down.......................................................................................................24
5.1 Recommended PC requirements...................................................................................... 24
5.2 Installation and software start up .................................................................................... 25
6 Operation............................................................................................................................ 26
6.1 Start up of the camera ................................................................................................... 26
6.2 Use a sheath................................................................................................................. 26
6.3 Snap-in and detach the tip ............................................................................................. 28
6.4 Recording images .......................................................................................................... 29
6.4.1 Intraoral mode................................................................................................... 29
6.4.2 Fluorescence mode............................................................................................. 31
6.4.3 Transillumination mode....................................................................................... 33
6.4.4 Combined Intraoral + Fluorescence mode............................................................. 35
6.4.5 Combined mode Intraoral + Fluorescence + Transillumination ................................ 36
6.5 Switching the camera off................................................................................................ 36
7 Reprocessing steps in accordance with ISO 17664 ...........................................................37
Instructions for use DIAGNOcam Vision Full HD
Table of contents
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7.1 Overview of the reprocessing options............................................................................... 37
7.2 Preparations at the site of use......................................................................................... 37
7.3 Disassembly.................................................................................................................. 37
7.4 Manual Reprocessing ..................................................................................................... 38
7.4.1 Manual external cleaning .................................................................................... 38
7.4.2 Manual internal cleaning ..................................................................................... 38
7.4.3 Manual external disinfection ................................................................................ 38
7.4.4 Manual internal disinfection ................................................................................. 39
7.4.5 Manual drying.................................................................................................... 39
7.5 Automated reprocessing................................................................................................. 40
7.5.1 pre-cleaning ...................................................................................................... 40
7.5.2 Automated internal and external cleaning and internal and external disinfection ....... 40
7.5.3 Automated drying .............................................................................................. 40
7.6 Care products and systems - Servicing ............................................................................ 40
7.7 Packaging ..................................................................................................................... 41
7.8 Sterilisation................................................................................................................... 41
7.9 Storage ........................................................................................................................ 41
8 Accessories ......................................................................................................................... 42
8.1 Foot Control Vision Full HD ............................................................................................. 42
8.1.1 Indications for use foot control ............................................................................ 42
8.1.2 Function description foot control .......................................................................... 42
8.1.3 Explanation of symbols foot control...................................................................... 42
8.1.4 Technical Specifications foot control ..................................................................... 43
8.1.5 Installation foot control ....................................................................................... 43
8.1.6 Operate foot control ........................................................................................... 44
8.1.7 Cleaning and servicing foot control....................................................................... 45
8.1.8 Terms of Use foot control.................................................................................... 45
9 Information concerning the electromagnetic compatibility according to EN IEC
60601-1-2........................................................................................................................... 46
9.1 Electromagnetic Transmissions ....................................................................................... 46
9.2 Immunity to electromagnetic interference ........................................................................ 47
9.3 Immunity to electromagnetic interference ........................................................................ 48
9.4 Recommended safe distance between portable and mobile HF telecommunications
equipment and the treatment device ............................................................................... 49
Instructions for use DIAGNOcam Vision Full HD
Table of contents
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Instructions for use DIAGNOcam Vision Full HD
1 User instructions |
1 User instructions
Dear User
Congratulations on purchasing this KaVo quality product. By following the notes
below you will be able to work smoothly, economically and safely.
© Copyright by KaVo Dental GmbH
KaVo and DIAGNOcam are either registered trademarks or trademarks of KaVo
Dental GmbH.
All other trademarks are property of their respective owners.
KaVo Original Factory Repair
In the event of a repair, please ship your product to the KaVo Original Factory
Repair using www.kavobox.com.
Please direct all questions regarding the product, service, and maintenance to
the following addresses.
Please refer to the serial number of the product in all inquiries!
Service-Hotline:
[phone]
[e-mail]
For more information, please visit: www.kavokerr.com
Target group
This document is intended for dentists and dental office staff. The startup sec-
tion is also intended for service technicians.
Abbreviations
Ab-
brevi-
ation
Explanation
IFU Instructions for use
CI Care instructions
SIFU Short instructions for use
AI Assembly instructions
TI Technician's instructions
IEC International Electrotechnical Commission
RI Repair instructions
RK Retrofitting kit
AS Assembly kit
CK Conversion kit
EP Enclosed parts
EMC Electromagnetic compatibility
5 / 52

Instructions for use DIAGNOcam Vision Full HD
1 User instructions |
6 / 52
Ab-
brevi-
ation
Explanation
PI Processing instructions
Abbreviation Explanation
Camera DIAGNOcam Vision Full HD
Tip Tip Vision Full HD
Fluorescence Cover Fluorescence Cover Vision Full HD
Sheath Sheath Vision Full HD
Foot control Foot Control Vision Full HD
Table holder Cradle Vision Full HD
Wall mount Wall Mount Vision Full HD
General marks and symbols
See Chapter on User Instructions/Hazard Levels
Important information for users and service technicians
Action request
CE mark (European Community). A product bearing this mark meets
the requirements of the applicable EC directive.
Medical device, labelling of medical devices
Thermodisinfectable
Sterilisable by steam
Information on the packaging
Material number
Serial number
Legal Manufacturer
Date of manufacture (YYYY-MM-DD)
CE mark for medical devices
Follow the electronic instructions for use
Note: Please note accompanying documents

Instructions for use DIAGNOcam Vision Full HD
1 User instructions | 1.1 Transport and storage
Follow the instructions for use
VDE mark
MET mark
Transportation and storage conditions
(Temperature range)
Transportation and storage conditions
(Air pressure)
Transportation and storage conditions
(Humidity)
Protect from moisture (Keep dry)
Protect from impact
HIBC Code
Hazard levels
The warning and safety notes in this document must be observed to prevent
personal injury and material damage. The warning notes are designated as
shown below:
DANGER
In cases which – if not prevented – directly lead to death or severe in-
jury.
WARNING
In cases which – if not prevented – can lead to death or severe injury.
CAUTION
In cases which – if not prevented – can lead to minor or moderate in-
jury.
NOTICE
In cases which – if not prevented – can lead to material damage.
1.1 Transport and storage
1.1.1 Damage in transit
In Germany
If the packaging is visibly damaged on delivery, please proceed as follows:
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Instructions for use DIAGNOcam Vision Full HD
1 User instructions | 1.1 Transport and storage
8 / 52
1. The recipient of the package must record the loss or damage on the delivery
receipt. The recipient and the representative of the shipping company must
sign this delivery receipt.
2. Leave the product and packaging in the condition in which you received it.
3. Do not use the product.
4. Report the damage to the shipping company.
5. Report the damage to KaVo.
6. Consult with KaVo first, before returning a damaged product.
7. Send the signed delivery receipt to KaVo.
If the product is damaged but there was no discernable damage to the pack-
aging on delivery, proceed as follows:
1. Report the damage to the shipping company immediately and no later than
7 days after delivery.
2. Report the damage to KaVo.
3. Leave the product and packaging in the condition in which you received it.
4. Do not use a damaged product.
Note
Failure on the part of the recipient to comply with any of the above-men-
tioned obligations will mean that the damage will be considered to have
arisen following delivery (in accordance with the General German Freight For-
warders' Terms and Conditions, Art. 28).
Outside Germany
Note
KaVo shall not be held liable for damage arising from transportation.
The shipment must be checked on arrival.
If the packaging is visibly damaged on delivery, please proceed as follows:
1. The recipient of the package must record the loss or damage on the delivery
receipt. The recipient and the representative of the shipping company must
sign this delivery receipt.
Without this evidence, the recipient will not be able to assert a claim for
damages against the shipping company.
2. Leave the product and packaging in the condition in which you received it.
3. Do not use the product.
If the product is damaged but there was no discernable damage to the pack-
aging on delivery, proceed as follows:
1. Report any damage to the shipping company immediately and no later than
7 days after delivery.
2. Leave the product and packaging in the condition in which you received it.
3. Do not use a damaged product.
Note
If the recipient fails to comply with any of the above-mentioned obligations,
the damage will be considered to have arisen following delivery
(in accordance with CMR law, Chapter 5, Art. 30).

Instructions for use DIAGNOcam Vision Full HD
1 User instructions | 1.2 Disposal
1.2 Disposal
Note
Any waste which is generated must be recycled or disposed of in strict com-
pliance with all applicable national regulations in a manner which is safe both
for people and the environment.
If you have any questions regarding proper disposal of the KaVo product,
please contact the KaVo branch.
1.2.1 Current packaging law
Dispose of and recycle the packaging appropriately in accordance with current
packaging law, employing waste management / recycling companies. Comply
with the comprehensive return system. KaVo has had its packaging licensed for
this purpose. Please comply with the regional public waste-disposal system.
1.3 Disposal of electronic and electrical devices
Note
According to the general WEEE Directive (Waste Electrical and Electronic
Equipment) and EU Directive 2012/19 concerning waste electrical and elec-
tronic equipment, we wish to point out that this product is subject to the
aforementioned Directive and must be subjected to special disposal within
Europe.
For more information, please visit www.kavo.com or contact your specialised
dental dealers.
For final disposal:
In Germany
To return an electrical device, you need to proceed as follows:
1. On the homepage www.enretec.de of enretec GmbH, you can download a
form for a disposal order under the menu item, eom. Download the disposal
order or complete it as an online order.
2. Enter the corresponding information to complete the order, and submit it as
an online order or by fax [phone] to enretec GmbH.
The following contact options are also available for questions and for initiat-
ing a disposal order:
Phone: [phone]
Email: [e-mail] and
Postal address: enretec GmbH, Geschäftsbereich eomRECYCLING®
Kanalstraße 17
D-16727 Velten
3. A unit that is not permanently installed will be picked up at the office.
A permanently installed unit will be picked up at the curb at your address on
the agreed date.
The owner or user of the device will have to bear the cost of disassembly,
transportation and packaging.
International
For country-specific information on disposal, contact your specialised dealers.
9 / 52

Instructions for use DIAGNOcam Vision Full HD
1 User instructions | 1.4 Terms and conditions of warranty
10 / 52
1.4 Terms and conditions of warranty
KaVo provides the final customer with a warranty that the product cited in the
handover certificate will function properly and guarantees zero defects in the
material or processing for a period of 12 months from data of purchase, subject
to the following conditions:
Upon justified complaints of flaws or a short delivery, KaVo will make good its
warranty by replacing the product free of cost or repairing it according to the
customer's wishes. Other claims of any nature whatsoever, in particular with
respect to compensation, are excluded. In the event of default and gross negli-
gence or intent, this shall only apply in the absence of mandatory legal regula-
tions to the contrary.
KaVo cannot be held liable for defects and their consequences due to natural
wear, improper cleaning or servicing, non-compliance with operating, servicing
or connection instructions, calcification or corrosion, contaminated air or water
supplies or chemical or electrical factors deemed abnormal or impermissible in
accordance with factory specifications.
The warranty does not usually cover bulbs, glassware, rubber parts and the col-
ourfastness of plastics.
Defects or their consequences that can be attributed to interventions on or
changes made to the product by the customer or a third party are excluded
from the warranty.
Claims from this warranty can only be asserted when the transfer form (copy)
belonging to the product has been sent to KaVo, and the original can be
presented by the operator or user.

Instructions for use DIAGNOcam Vision Full HD
2 Safety | 2.1 Infection hazard
2 Safety
Note
All serious events occurring in relation to the product must be reported to the
manufacturer and the competent authority of the member state, in which the
user and/or patient resides.
The instructions for use are a component of the product and must be read care-
fully prior to use and be accessible at all times.
The device may only be used in accordance with the intended use, any other
type of use is not permitted.
2.1 Infection hazard
Patients, users or third parties could be infected by contaminated medical
devices.
▶Take suitable personal protective measures.
▶Follow the instructions for use of the components.
▶Before initial startup and after each use, reprocess the product and ac-
cessories appropriately.
▶Carry out the reprocessing as described in the instructions for use. The pro-
cedure has been validated by the manufacturer.
▶If you deviate from this procedure, it is essential to make sure that the re-
processing is effective.
▶Reprocess the product and accessories appropriately before disposal.
2.2 Technical condition
A damaged device or components could injure patients, users and third parties.
▶Only operate devices or components if they are undamaged on the outside.
▶Check that the device is working properly and is in satisfactory condition
before each use.
▶Have parts with sites of breakage or surface changes checked by the Ser-
vice.
▶Do not pull on the USB cable and do not kink the cable.
▶If product irregularities occur, immediately shut down the product and have
the service personnel carry out repair work.
▶If image faults occur, immediately shut down the product and have the ser-
vice personnel carry out repair work.
2.3 Accessories and combination with other equipment
Use of un-authorised accessories or un-authorised modifications of the device
could lead to injury.
▶Only use accessories that have been approved for combination with the
product by the manufacturer.
▶Only use accessories that are equipped with standardised interfaces.
▶Only use consumables that have been approved for combination with the
product by the manufacturer.
▶Do not make any modifications to the device unless these have been ap-
proved by the manufacturer of the product.
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Instructions for use DIAGNOcam Vision Full HD
2 Safety | 2.4 Qualification of personnel
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▶The USB cable of the camera must not be changed or extended.
This may damaged the tips.
▶When you attach the tip please make sure to attach the tip carefully to the
camera.
▶Do not attach or remove the tip in a straight line.
▶Position the tip on one side of the housing and carefully snap-in into the op-
posite side.
▶Check on the stable positioning of the tip.
2.4 Qualification of personnel
Application of the product by users without the appropriate medical training
could injure the patients, the users or third parties.
▶Make sure that the user has read and comprehends the instructions for use.
▶Make sure that the user has read and comprehends the national and re-
gional regulations.
▶The device may be used only if the user has completed the appropriate
medical training.
2.5 Electrical shock
Damage or connection to external devices can lead to electrical shock and in-
jury to patient, user and third parties.
▶Make sure that the product is undamaged. Do not use it again if it dropped.
▶Connect the product to a laptop/PC approved in accordance with IEC
60601-1, IEC 60950-1 or IEC 62368-1.
2.6 Aspiration and danger of suffocation
Inserting the medical device too deeply into the throat/pharynx can lead to
vomiting and aspiration of the vomit.
▶Do not insert the device into the throat/pharynx.
2.7 Laceration
Improper use can lead to laceration.
▶Check the product and accessories for external damage before use.
2.8 Electromagnetic fields
Electromagnetic fields might interfere with the functions of implanted systems
(such as pacemakers).
▶Ask patients if they have a cardiac pacemaker or other system implanted
and counsel them about the risks before you start the treatment.
▶Switch the product off in treatment rooms with other forms of energy (e.g.
X-ray, laser, rotating instruments).

Instructions for use DIAGNOcam Vision Full HD
2 Safety | 2.9 LED light
2.9 LED light
LED light is associated with the risk of eye damage.
▶Do not direct LED illumination towards the eyes and do not look into the
LED exit opening.
▶Do not operate the product when the housing is damaged or opened.
2.10 Service and repair
Repairs and servicing may only be performed by trained service personnel. The
following persons are authorised to do this:
▪ Service technicians of KaVo branches after the appropriate product training
▪ Service technicians of KaVo authorised dealers after the appropriate
product training
▶Only use spare parts that comply with the specification for repair; original
KaVo spare parts comply with the specification.
Note
If a repair is done with NON-KaVo original spare parts, this may constitute a
product modification that leads to the loss of CE conformity. In the event of
damage, the responsibility is with the service company or the operator.
The introduction into the market of a modified product, where there is reas-
onable suspicion that the safety and health of patients or users may be jeop-
ardised, is prohibited by the German medical device law §4, section 1 no. 1
and requires a separate conformity check.
Cleansers and disinfectants that have not been approved can damage the
plastic housing possibly leading to hairline cracks and other damage which can
ultimately cause hazards.
Damage from the ingress of liquids.
▶Make sure that no liquid enters the inside of the device.
Servicing foot control:
▶If needed, exchange the battery.
2.11 Cybersecurity
The camera device uses common open standards for video streaming and
device interaction in order to work with your application software.
The camera device does not have any internal functions to interact with any
network services.
▶Please read the manual of your application software for further information.
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Instructions for use DIAGNOcam Vision Full HD
3 Product description | 2.11 Cybersecurity
14 / 52
3 Product description
The camera enables various applications in health facilities/dental offices, dental
clinics, orthodontics and oral and maxillary surgery. Connected to a computer,
a monitor and imaging software, the DIAGNOcam Vision Full HD can be used to
create and save images and videos.
Possible applications:
1. Intraoral mode
The camera can be used with or without a tip. This mode is used to record
images and videos of the teeth in the oral cavity including macro and facial
images.
2. Fluorescence mode
The camera can be used with or without a tip. This mode is used to record
images and videos to support the diagnosis of caries (mainly in the occlusal
area) and plaque by means of fluorescent images.
3. Transillumination mode
The camera can only be used with a tip. This mode is used to record images
and videos to support the diagnosis of carious lesions above the gingiva
(mainly in the proximal and occlusal area) and cracks and for monitoring
the progress of such lesions. The DIAGNOcam Vision Full HD supports the
indications mentioned above by transillumination of the dental enamel.
Contraindications:
▪ The ability to diagnose is strongly limited or even made impossible by
dental prosthesis (e.g. crowns) and very large fillings.
▪ Subgingival caries cannot be diagnosed.
▪ Confirmation of diagnosis solely with the DIAGNOcam Vision Full HD (the
DIAGNOcam Vision Full HD is intended for supportive caries diagnosis, es-
pecially for the early detection of caries).

Instructions for use DIAGNOcam Vision Full HD
3 Product description | 3.1 Intended use
3.1 Intended use
Indications for use:
The application range of the DIAGNOcam Vision Full HD ranges from images in
the oral cavity of the patient to images taken outside the mouth (i.e. facial im-
ages). The images support diagnosis by detection of smooth surface caries, oc-
clusal caries, proximal caries, initial caries, secondary caries, and tooth frac-
tures. The DIAGNOcam Vision Full HD is designed for use by a trained profes-
sional in the field of dentistry.
Proper use:
According to these regulations, this product may only be used for the described
application by a properly trained user. You need to comply with the following:
▪ the applicable health and safety regulations
▪ the applicable accident prevention regulations
▪ these Instructions for use
According to these regulations, the user is required:
▪ to only use equipment that is operating correctly
▪ adhere to the specified intended use
▪ to protect him or herself, the patient and third parties from hazards
▪ to prevent contamination from the product
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Instructions for use DIAGNOcam Vision Full HD
3 Product description | 3.2 Symbols on product and rating plate
16 / 52
3.2 Symbols on product and rating plate
①Rating plate ④Date of manufacture
②Serial number ⑤Material number
③HIBC Code
Accompanying documents
Please note the electronic instructions for use
Please note the instructions for use
Please note the instructions for use
HIBC Code
Certification
CE mark according to Medical Devices Directive EC 93/42
VDE mark
MET mark
Medical device, labelling of medical devices
Product characteristics
Legal Manufacturer
Date of manufacture (YYYY-MM-DD)
SN Serial number (XXXXXXX)
REF Material number (X.XXX.XXXX)
Type B applied part
Direct current
Operating mode: continuous operation with intermittent load
IP 44 Degree of protection against ingress of solid and liquid substances

Instructions for use DIAGNOcam Vision Full HD
3 Product description | 3.3 Product configurations
Disposal instructions, see user instructions
3.3 Product configurations
The camera is available with two different lengths of cable:
Standard configuration
(1.011.1213)
Cable length 2.5 m
Used in combination with treatment
unit (1.013.1500)
Cable length 1.30 m
3.4 Technical Specifications
Complete system
Power consumption: max. 0.5 A
Supply voltage 5V
Cable length (standard) 2.5 m
Weight 190 g
Length (standard) 255mm
Diameter approx. 30 mm
Interface USB 2 / USB 3
Mode: intermittent operation
Operating time 10 minutes
Pause time 10 minutes
Illumination
In the handpiece 2x LEDs for Fluorescence mode
2x LEDs for Intraoral mode
In the tip 2x LEDs for Transillumination mode
Optical system
Image size 1920 x 1080 px
Work area 2 mm (macro) to 120 mm (facial)
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Instructions for use DIAGNOcam Vision Full HD
3 Product description | 3.4 Technical Specifications
18 / 52
Operating conditions
Ambient temperature +10 to + 30 oC
Air pressure 800 to 1060 hPa
Rel. humidity 5% to 95% non-condensing
Max. altitude for operation max. 2000 m
Operating environment
Permissible installation sites Indoor use, portable
Degree of soiling 2
Storage and transportation conditions
Ambient temperature -10 to +55 oC
Air pressure 700 to 1060 hPa
Rel. humidity 5% to 95% non-condensing

Instructions for use DIAGNOcam Vision Full HD
3 Product description | 3.5 Scope of delivery
3.5 Scope of delivery
65
7
1
234
①Tip (1 piece) ⑤USB connection cable
②Fluorescence Cover (1 piece) ⑥Table holder
③Camera ⑦Sheath (100 pieces)
④Control panel
The USB cable is used to connect the camera to the computer and to send the
captured image to the imaging software. The DIAGNOcam Vision Full HD needs
an imaging software that is released for connection to the camera.
The function of the camera depends on the selected mode, which can be selec-
ted using the control panel.
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Instructions for use DIAGNOcam Vision Full HD
3 Product description | 3.6 System components
20 / 52
3.6 System components
Camera
3
2
1
① Window with 2 LEDs each for Intraoral Mode and Fluorescence
Mode
② Tip holder
③ Control panel
See also:
26 Operation, Page 26
Camera with tip attached
3
2
1
① Tip
② Control panel
③ Camera
See also:
26 Operation, Page 26
Tip
1
① 2x light exit for Transillumination mode
See also:
26.3 Snap-in and detach the tip, Page 28
Fluorescence Cover
Fluorescence Cover is used in Fluorescence mode.
See also:
26.4.2 Fluorescence mode, Page 31
Sheaths
The sheaths are used for infection prevention.
Foot control
The foot control can be used as an alternative to the trigger button
on the control panel of the camera.
Briefly touching the foot control ones triggers the capture of an im-
age and/or starts/stops a video.
If the foot control is touched for a longer period of time (approxim-
ately one second), the image/video is saved in the imaging software
(if supported).
See also:
28.1 Foot Control Vision Full HD, Page 42
Table holder
The table holder is to be placed on the dentist element and can be
used to store the camera.
Once the camera is placed in the table holder, it shuts off automatic-
ally. Once the camera is taken out of the table holder, it switches on
automatically.