KaVo DIAGNOcam 2170 U User manual

Instructions for use
DIAGNOcam 2170 U

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 User guide .................................................................................................................... 5
1.1.1 Abbreviations..................................................................................................... 5
1.1.2 Symbols............................................................................................................ 5
1.1.3 Target group ..................................................................................................... 5
1.1.4 Service ............................................................................................................. 6
1.1.5 Terms and conditions of warranty ....................................................................... 6
2 Safety.................................................................................................................................. 7
2.1 Protective equipment ..................................................................................................... 7
2.2 Description of safety instructions..................................................................................... 7
2.2.1 Warning symbol................................................................................................. 7
2.2.2 Structure........................................................................................................... 7
2.2.3 Description of hazard levels................................................................................. 7
2.3 Purpose – Intended use.................................................................................................. 8
2.3.1 General............................................................................................................. 8
2.3.2 Product-specific.................................................................................................. 8
2.4 Safety instructions......................................................................................................... 9
2.4.1 Data backup ...................................................................................................... 9
2.4.2 Backup copies.................................................................................................... 9
2.5 Disposal of electronic and electrical devices ...................................................................... 10
2.5.1 Current packaging law ........................................................................................ 11
2.6 Safety instructions......................................................................................................... 11
3 Description of the product..................................................................................................13
3.1 System components ...................................................................................................... 13
3.1.1 Handpiece ......................................................................................................... 13
3.1.2 Handpiece with attached tip ................................................................................ 14
3.1.3 Occlusal tip (Tip large, Tip small) ......................................................................... 14
3.2 Operating buttons and ring switch ................................................................................... 15
3.3 Symbols on product and rating plate ............................................................................... 16
3.4 Technical Specifications.................................................................................................. 17
4 Commissioning ................................................................................................................... 19
4.1 Connecting the camera .................................................................................................. 19
4.1.1 Dentist element ................................................................................................. 19
4.2 Carry out a safety check................................................................................................. 20
5 Operation............................................................................................................................ 21
5.1 Attach and remove a tip ................................................................................................. 21
5.2 Turning on/off ............................................................................................................... 23
5.3 Occlusal use.................................................................................................................. 23
5.4 Software....................................................................................................................... 24
5.4.1 Switching the camera on and off.......................................................................... 25
5.4.2 Taking and saving an image................................................................................ 25
5.5 Determining findings and diagnosis ................................................................................. 25
6 Reprocessing methods according to ISO 17664 ................................................................27
6.1 Preparations for cleaning ................................................................................................ 27
6.2 Cleaning ....................................................................................................................... 27
Instructions for use DIAGNOcam 2170 U
Table of contents
3 / 38

6.3 Manual cleaning ............................................................................................................ 27
6.4 Machine cleaning ........................................................................................................... 28
6.5 Disinfection................................................................................................................... 28
6.5.1 Manual disinfection............................................................................................. 28
6.5.2 Automated disinfection ....................................................................................... 28
6.6 Sterilisation................................................................................................................... 28
6.7 Control and functional checks ......................................................................................... 29
6.7.1 General............................................................................................................. 29
6.7.2 Checking the tips ............................................................................................... 29
7 Troubleshooting ................................................................................................................. 30
8 Accessories ......................................................................................................................... 31
9 Information concerning the electromagnetic compatibility according to EN IEC
60601-1-2........................................................................................................................... 32
9.1 Electromagnetic Transmissions ....................................................................................... 32
9.2 Resistance to electromagnetic interference....................................................................... 32
9.3 Immunity to electromagnetic interference ........................................................................ 33
9.4 Recommended safe distance between portable and mobile HF telecommunications
equipment and the treatment unit................................................................................... 35
Instructions for use DIAGNOcam 2170 U
Table of contents
4 / 38

Instructions for use DIAGNOcam 2170 U
1 User instructions | 1.1 User guide
1 User instructions
1.1 User guide
Requirement
Read these instructions prior to first startup to avoid misuse and prevent dam-
age.
1.1.1 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
PI Processing instructions
1.1.2 Symbols
See section on Hazard levels
Important information for users and technicians
CE mark (European Community). A product bearing this mark meets
the requirements of the applicable EU directive.
Medical device, labelling of medical devices
Action required
1.1.3 Target group
This document is for dentists and dental office staff.
5 / 38

Instructions for use DIAGNOcam 2170 U
1 User instructions | 1.1 User guide
6 / 38
1.1.4 Service
Service hotline:
[phone]
[e-mail]
Please refer to the serial number of the product in all inquiries!
For further information, please visit: www.kavo.com
Technical customer service
The technical support for KaVo products is primarily offered by the dental sup-
plier.
KaVo provides ongoing training and special courses for specialised dealer tech-
nicians.
To guarantee constant readiness for use and maintenance of value of the KaVo
products, the products must be serviced regularly.
1.1.5 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 2170 U
2 Safety | 2.1 Protective equipment
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.
2.1 Protective equipment
Note
Since this is a class 1 laser medical device, no personal protective equipment
needs to be worn according to the EC directive.
2.2 Description of safety instructions
2.2.1 Warning symbol
Warning symbol
2.2.2 Structure
DANGER
The introduction describes the type and source of the hazard.
This section describes potential consequences of non-compliance.
▶The optional step includes necessary measures for hazard prevention.
2.2.3 Description of hazard levels
Safety instructions distinguishing between three hazard levels are used in this
document to prevent personal and property damage.
CAUTION
CAUTION
indicates a hazardous situation that can cause damage to property or mild to
moderate injuries.
WARNING
WARNING
indicates a hazardous situation that can lead to serious or fatal injury.
DANGER
DANGER
indicates a maximal hazard due to a situation that can directly cause death or
fatal injury.
7 / 38

Instructions for use DIAGNOcam 2170 U
2 Safety | 2.3 Purpose – Intended use
8 / 38
2.3 Purpose – Intended use
2.3.1 General
The overarching guidelines and/or national laws, national regulations and the
rules of technology applicable to medical devices for startup and use of the
KaVo product for the intended indications for use must be applied and followed.
This KaVo product is intended for use in dentistry only. Any other type of use is
not permitted.
"Proper use" includes compliance with all instructions for use and the inspection
and maintenance intervals.
The functional safety and proper condition of the device must be checked be-
fore each use of the device.
The applicable national legal regulations must be observed during the use of the
device, in particular the following:
▪ Applicable regulations governing the connection and startup of medical
devices.
▪ Current occupational safety regulations.
▪ Current accident prevention regulations.
It is a responsibility of the user:
▪ to only use equipment that is operating correctly,
▪ to protect him or herself, the patient and third parties from hazards, and
▪ to prevent contamination from the product
Note
The product must be cleaned and serviced according to instructions if it is not
to be used for an extended period of time.
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.
2.3.2 Product-specific
The DIAGNOcam 2170 is a diagnostic aid for the detection of open or incipient
carious lesions above the gingiva and for monitoring the progress of such le-
sions.
Indications:
▪ Detection of smooth surface caries
▪ Detection of occlusal carries
▪ Detection of proximal caries
▪ Detection of initial caries
▪ Detection of secondary caries

Instructions for use DIAGNOcam 2170 U
2 Safety | 2.4 Safety instructions
▪ Detection of cracks
Contraindications:
▪ Diagnosability is strongly limited or restricted by a restorations (such as
crowns) and very large fillings.
▪ Subgingival caries cannot be diagnosed.
▪ The DIAGNOcam is designed solely for use to confirm diagnoses (the DIA-
GNOcam is intended for supportive caries diagnosis, especially for the early
detection of caries).
The device is for use in a dentist's office or dental clinic.
The device is a class IIa medical device according to EC Directive 93/42/EEC.
The illumination corresponds to laser class 1 according to EN 60825-1.
Note
Only a dentist may diagnose pathological changes in the tooth substance.
2.4 Safety instructions
2.4.1 Data backup
CAUTION
Hard disk defect
Data loss
▶Create regular backup copies!
▶Keep backup copies in a safe location.
The user is responsible for backing up data.
KaVo recommends daily back-up.
Note
For security reasons the database and all document files should be backed up
regularly (KaVo recommends every working day). A data backup schedule
should be prepared.
2.4.2 Backup copies
Such a copy is also called a backup. It should not be confused with the export
of data. There are various backup strategies.
A distinction is made between:
▪ full backup (backs up all data on the hard disk).
▪ incremental backup (backs up only data that has been changed since the
previous backup).
A full backup is not suitable for daily implementation because of the time re-
quired. A combination of full and incremental backup is generally used. All data
are backed up at a specific time and then - at regular intervals - only modified
data are backed up.
9 / 38

Instructions for use DIAGNOcam 2170 U
2 Safety | 2.5 Disposal of electronic and electrical devices
10 / 38
Note
A hard disk failure can also occur during a backup. KaVo recommends: Never
overwrite the current backup copy.
Note
The computer technician/system administrator of your office is familiar with
the current technology for backup copies and making backups.
2.5 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.
Before disassembly / disposal, the product must be completely reprocessed
(disinfected, sterilised) according to the chapter on "Reprocessing methods".
For more information, please contact KaVo (www.kavo.com) or your special-
ised dental dealer.
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.

Instructions for use DIAGNOcam 2170 U
2 Safety | 2.6 Safety instructions
2.5.1 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.
2.6 Safety instructions
WARNING
Danger of injury from electric current.
Electric shock.
▶Stop working if the device is damaged!
▶Connect the device only to a PC/laptop that is approved according to IEC
60601-1 or IEC 60950.
▶Do not use the device on patients or place it near patients with the probe
removed.
▶Do not use the device after it has been dropped.
WARNING
Danger of suffocation.
Vomiting can be triggered by inserting the device too far.
Aspiration of vomit.
▶Keep the device away from the patient's throat!
WARNING
Blinding hazard from invisible laser.
Eye damage.
▶Do not point the device toward the eyes when the laser is active!
▶Do not operate the device when the housing is damaged or opened.
▶Do not use the handpiece on the patient when the tips are not attached.
▶Do not look into the handpiece's aperture for the light when the tip is re-
moved.
WARNING
Hazard from electromagnetic radiation.
Interference with other devices.
▶Do not use the device on patients with pacemakers!
▶Turn off devices situated in the treatment room that are sources of hazard-
ous energy (such as x-ray machines, lasers, and rotating instruments)!
CAUTION
The product may be damaged by kinking or pinching the USB cable.
Irreversible breakage of the electrical lines in the USB cable.
▶Do not pull on the USB cable!
CAUTION
Damage from improper handling.
Destruction of the DIAGNOcam housing and internal components.
▶Do not use the DIAGNOcam to move the dentist element!
▶Do not lean on the DIAGNOcam while it is situated in the holder.
▶Use the handpiece on the patient only when the probe is attached!
11 / 38

Instructions for use DIAGNOcam 2170 U
2 Safety | 2.6 Safety instructions
12 / 38
CAUTION
Risk of infection due to soiled or contaminated DIAGNOcam.
Infection.
▶Recondition the DIAGNOcam handpiece and tips after use.
CAUTION
Risk of laceration from improper use
Laceration
▶Do not use the handpiece on the patient without an adapted probe.
▶Do not use a damaged device on a patient.
▶Do not use the device on a patient when the probe is damaged.
CAUTION
Powerful laser
The pulp cavity may become heated
▶Restrict use to a maximum of 1 minute per tooth.
CAUTION
Biological contamination
Infection
▶Do not use the device on wounds / exposed tissue.

Instructions for use DIAGNOcam 2170 U
3 Description of the product | 3.1 System components
3 Description of the product
The DIAGNOcam is a mobile device that is delivered with a firmware for the
treatment centre for controlling the camera functions and a computer-based
image processing software for showing / displaying, storing / saving the im-
ages, and for optional recording of live streams.
The device uses the DIFOTI-Technology (Digital Imaging Fiberoptic Transillu-
mination) as the functional principle. TheDIAGNOcam produces images reminis-
cent of X-ray images, but which are completely radiation free - by means of a
light that is especially adapted to this examination method.
The tooth structures allow the passage of light from the entry site to the cam-
era. Areas that block light transmission (e.g. carious lesions) show up clearly as
well delimited, dark areas. A digital camera captures the actual situation and
makes it visible in real-time on the screen.
3.1 System components
3.1.1 Handpiece
321
4
①Window for camera lens system ③Contact surface for the ring switch
②Aperture for the laser ④Forked light barriers for probe iden-
tification
13 / 38

Instructions for use DIAGNOcam 2170 U
3 Description of the product | 3.1 System components
14 / 38
3.1.2 Handpiece with attached tip
3 6
2
154
①Occlusal tip ④Control button 2
②Ring switch ⑤Handpiece
③Control button 1 ⑥USB 2.0 cable with anti-kink sleeve
and DC/DC voltage transformer
3.1.3 Occlusal tip (Tip large, Tip small)
①Opening for camera window

Instructions for use DIAGNOcam 2170 U
3 Description of the product | 3.2 Operating buttons and ring switch
①Aperture for laser beam
3.2 Operating buttons and ring switch
The ring switch ③ with six positions can be used to generate still in all relevant
positions.
Actuation Ring switch ③Function
Briefly when the device is turned off Laser and camera turn on
(= the device is ready to use)
15 / 38

Instructions for use DIAGNOcam 2170 U
3 Description of the product | 3.3 Symbols on product and rating plate
16 / 38
Actuation Ring switch ③Function
Briefly when the device is turned on Create still images that are automatic-
ally saved
Long Laser and camera are being turned off
Pressing Control button 1④Feature
Brief Select the next tooth in the tooth chart
(anticlockwise direction)
Pressing Control button 2⑤Feature
Brief Select the next tooth in the tooth chart
(in a clockwise direction)
3.3 Symbols on product and rating plate
1
①Rating plate
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 for medical devices
EAC conformity mark (Eurasian Conformity)
Medical device, labelling of medical devices
Product characteristics
Made in Germany
Type Device type DIAGNOcam – Month of manufacture/year of manufacture
REF Material number
SN Serial number

Instructions for use DIAGNOcam 2170 U
3 Description of the product | 3.4 Technical Specifications
Classification (applied part type BF)
Labelling according to 2002/96/EC
Can be sterilised with steam at 134 °C -1 °C / +4 °C (273 °F -1.6 °F /
+7.4 °F)
3.4 Technical Specifications
Complete system
Power consumption: max. 0.5 A
Supply voltage 5V
Hose length 1.3 m
Weight 190 g
Protection class IP 44
Length approx. 245 mm
Diameter 30mm
Protection class IP indicates the scope of protection by a housing against the in-
gress of solid foreign matter and against the ingress of water.
The first number 4 means protection against ingress of solid foreign matter ≥
1mm in diameter.
The second number 4 indicates protection against splashing water.
Image detector
Type CMOS
Format ¼“
Monochrome 8 Bit
Resolution 640 (H) x 480 (H)
Illumination
Type Laser diode
Number 2
Wavelengths 780 nm
Opt. power 15 mW
Opt. power according to IEC
60825-1:2014
Safety of laser products - Part 1:
Equipment classification and require-
ments
max. 1 mW (Class I)
17 / 38

Instructions for use DIAGNOcam 2170 U
3 Description of the product | 3.4 Technical Specifications
18 / 38
Optical system
Image angle 105o
Viewing direction 80o
Focusing distance 4.5mm
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
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 2170 U
4 Commissioning | 4.1 Connecting the camera
4 Commissioning
Note
A PC is required for the operation of the camera (not included in the delivery)
Note
The DIAGNOcam may only be used on equipment which at least fulfils the
standard EN DIN ISO 60950.
Note
The distance between the PC and camera cable (floor terminal box) must not
exceed 10 m. High-quality, active USB extension (maximum 5 m long each)
must be used. (KaVo recommends one or two USB extensions 5m Mat. no.
1.004.6953)
4.1 Connecting the camera
4.1.1 Dentist element
▶Insert the USB plug of the camera at the connection.
CAUTION
The connecting cable is firmly connected to the camera handpiece.
Product damage
▶Do not remove the connecting cable from the camera handpiece.
Note
Defective camera function.
The camera can indicate a defective function if the PC, to which the camera is
connected, is set in into idle, standby or hibernation mode.
▶Turn off the PC and switch off.
19 / 38

Instructions for use DIAGNOcam 2170 U
4 Commissioning | 4.2 Carry out a safety check.
20 / 38
CAUTION
Wrong insertion into the USB socket.
USB - plug can only be inserted into the correct position. Forceful insertion
leads to destruction of the plug.
▶Check the correct position before inserting the plug.
After connecting the camera to the PC, check the correct installation of the
camera on the PC. The camera uses uses system drivers in windows, installa-
tion follows automatically by plugging into a USB port.
Note
If the camera is plugged into another USB port of the PC, the installation for
this USB port will be automatically repeated.
Note
In the case of turbulent video operation, an unsuitable front USB port has
been used which is not optimally connected to the main board of the PC. Plug
the camera into an alternative USB port of the PC.
Verification of correct installation:
▪ A further USB input device is displayed under device manager (human in-
terface device) following connection of the camera.
▪ A device "DIAGNOcam" is displayed in the device manager under image
processing device.
Note
An additional software e.g. Conexio is required for the display / storage of
camera images on the PC.
The assembly of the camera is described in the instructions for assembly and
use of the respective treatment unit.
4.2 Carry out a safety check.
WARNING
Danger of injury from electric current.
Electric shock.
▶Carry out a safety check after connecting the camera.
▶Do not continue working with a damaged camera!
▶Only connect accessories that conform with IEC 60601-1, IEC 60950 or IEC
601010 to the system.
▶Let the service technician carry out the safety check.
▶Check the housing and the connection cable of the camera for cracks and
damage.
See also:
2Instructions for use of the treatment unit.