Page 1
Instructions for use
DIAGNOcam 2170
Always be on the safe side.
Page 2
Distributed by:
KaVo Dental GmbH
Bismarckring 39
D-88400 Biberach
Phone +49 7351 56-0
Fax +49 7351 56-1488
Manufacturer:
Kaltenbach & Voigt GmbH
Bismarckring 39
D-88400 Biberach
www.kavo.com
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Instructions for use DIAGNOcam 2170
Table of contents
Table of contents
1 User instructions ........................................................................................................................................ 3
1.1 User guide ....................................................................................................................................... 3
1.1.1 Abbreviations ...................................................................................................................... 3
1.1.2 Symbols .............................................................................................................................. 3
1.1.3 Target group ....................................................................................................................... 3
1.1.4 Service ............................................................................................................................... 3
2 Safety ........................................................................................................................................................ 5
2.1 Protective equipment ....................................................................................................................... 5
2.2 Description of safety instructions ..................................................................................................... 5
2.2.1 Warning symbol .................................................................................................................. 5
2.2.2 Structure ............................................................................................................................. 5
2.2.3 Description of hazard levels ............................................................................................... 5
2.3 Purpose – Intended use .................................................................................................................. 6
2.3.1 General information ............................................................................................................ 6
2.3.2 Product-specific .................................................................................................................. 6
2.4 Disposal of electronic and electrical devices ................................................................................... 7
2.5 Safety instructions ........................................................................................................................... 8
3 Product description .................................................................................................................................. 10
3.1 System components ...................................................................................................................... 10
3.1.1 Handpiece ........................................................................................................................ 10
3.1.2 Handpiece with attached tip ............................................................................................. 10
3.1.3 Occlusal tip (Tip large, Tip small) ..................................................................................... 11
3.2 Operating buttons and ring switch ................................................................................................. 12
3.3 IDs and labels ................................................................................................................................ 13
3.3.1 Rating plate ...................................................................................................................... 13
3.4 Technical Specifications ................................................................................................................ 13
4 First use ................................................................................................................................................... 15
4.1 Hardware requirements ................................................................................................................. 15
4.2 Software installation ...................................................................................................................... 15
4.2.1 Start the installation routine .............................................................................................. 15
4.2.2 Installing a single-user system ......................................................................................... 16
4.2.3 Installing a multiple-user system ...................................................................................... 23
4.2.4 Installing a VDDS interface .............................................................................................. 31
4.3 Remote maintenance by means of Netviewer ............................................................................... 32
4.3.1 Starting Netviewer directly through button in KiD ............................................................. 33
5 Operation ................................................................................................................................................. 35
5.1 Attach and remove a tip ................................................................................................................ 35
5.2 Turning on/off ................................................................................................................................ 37
5.3 Occlusal use .................................................................................................................................. 38
5.4 Brief instructions for the KiD .......................................................................................................... 39
5.5 Determining findings and diagnosis .............................................................................................. 39
5.6 DIAGNOcam Function ................................................................................................................... 40
6 Reconditioning methods according to EN ISO 17664 ............................................................................. 54
6.1 Preparations for cleaning .............................................................................................................. 54
6.2 Cleaning ........................................................................................................................................ 54
6.3 Manual cleaning ............................................................................................................................ 54
6.4 Machine cleaning .......................................................................................................................... 55
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Instructions for use DIAGNOcam 2170
Table of contents
6.5 Disinfection .................................................................................................................................... 55
6.5.1 Manual disinfection ........................................................................................................... 55
6.5.2 Automated disinfection ..................................................................................................... 56
6.6 Sterilisation .................................................................................................................................... 56
6.7 Control and functional checks ....................................................................................................... 57
6.7.1 General ............................................................................................................................. 57
6.7.2 Checking the tips .............................................................................................................. 57
7 Troubleshooting ....................................................................................................................................... 58
8 Accessories ............................................................................................................................................. 59
9 Data on electromagnetic compatibility according to EN 60601-1-2 ......................................................... 61
9.1 Electromagnetic Transmissions .................................................................................................... 61
9.2 Resistance to electromagnetic interference .................................................................................. 61
9.3 Immunity to electromagnetic interference ..................................................................................... 62
9.4 Recommended safe distance between portable and mobile HF telecommunications equip‐
ment and the treatment unit .......................................................................................................... 64
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Instructions for use DIAGNOcam 2170
1 User instructions | 1.1 User guide
1 User instructions
1.1 User guide
Requirement
Read these instructions prior to first use to avoid misuse and prevent damage.
1.1.1 Abbreviations
Abbre‐
viation
IfU Instructions for Use
CI Care instructions
AI Assembly instructions
TI Technician's instructions
SC Safety checks
IEC International Electrotechnical Commission
RI Repair instructions
EMC Electromagnetic compatibility
PI Processing instructions
Explanation
1.1.2 Symbols
1.1.3 Target group
This document is for dentists and dental office staff.
1.1.4 Service
Service hotline:
+49 7351 56-2700
Service.Multimedia@kavo.com
Please indicate the product serial number in all requests.
Additional information can be obtained at: www.kavo.com
See the Safety/Warning Symbols section
Important information for users and technicians
CE mark (European Community). A product bearing this mark meets the
requirements of the applicable EU directive.
Action required
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Instructions for use DIAGNOcam 2170
1 User instructions | 1.1 User guide
Technical customer service
The technical support for KaVo products is primarily offered by the dental suppli‐
er.
KaVo provides ongoing training and special courses for dealer technicians.
To guarantee constant readiness for use and maintenance of value of the KaVO
products, the products must be regularly serviced.
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Instructions for use DIAGNOcam 2170
2 Safety | 2.1 Protective equipment
2 Safety
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 with 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 death or fatal injury.
DANGER
DANGER
indicates a maximal hazard due to a situation that can directly cause death or
fatal injury.
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Instructions for use DIAGNOcam 2170
2 Safety | 2.3 Purpose – Intended use
2.3 Purpose – Intended use
2.3.1 General information
The overarching guidelines and/or national laws, national regulations and the
rules of technology applicable to medical devices for start-up and use of the KaVo
product for the intended purpose 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 user must ensure that the unit works properly and is in satisfactory condition
before each use.
During use, national legal regulations must be observed, in particular:
▪ the applicable health and safety regulations
▪ the applicable accident prevention regulations
Users have a duty to:
▪ Only use equipment that is operating correctly
▪ to protect himself, the patient and third parties from danger.
▪ to avoid 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 a manner
which is safe both for people and for the environment. This must be done in strict
compliance with all applicable national regulations.
Questions on proper disposal of the KaVo product can be answered by the KaVo
branch.
2.3.2 Product-specific
The DIAGNOcam is designed exclusively to support the identification of open or
incipient carious lesions above the gingiva and for monitoring the progress of
such lesions.
Indications:
▪ Detection of smooth surface caries
▪ Detection of occlusal carries
▪ Detection of proximal caries
▪ Detection of initial caries
▪ Detection of secondary caries
▪ Detection of cracks
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Instructions for use DIAGNOcam 2170
2 Safety | 2.4 Disposal of electronic and electrical devices
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 DIAG‐
NOcam is intended for supportive caries diagnosis, especially for the early de‐
tection 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 Disposal of electronic and electrical devices
Note
According to EC directive 2002/96 concerning used electrical and electronic de‐
vices, this product is subject to the cited directive and must be disposed of ac‐
cordingly within Europe.
Before disassembling / disposing of the product, it must be completely processed
(disinfected, sterilized) according to the section "Preparation methods"
Additional information can be obtained from KaVo (www.kavo.com) or your den‐
tal supplier.
For final disposal, contact:
Germany
To return an electrical device, proceed as follows:
1. At the homepage www.enretec.de of enretec GmbH, you can download a form
for a disposal request under the menu item eom, or you can use it as an online
request.
2. Fill out the request with the corresponding information, and send it as an on‐
line request or by fax (+49(0)3304 3919 590) to enretec GmbH.
The following avenues are also available for questions and for initiating a dis‐
posal request:
Telephone: +49 (0) 3304 3919 500
E-mail: pickup@eomRECYCLING.com and
Post: enretec GmbH, eomRECYCLING Department
Kanalstraße 17
16727 Velten
3. Yourmovabledevice will be picked up in your practice, and yourpermanently
installedunit will be picked up at the curb at your address on the agreed dead‐
line.
The owner or user of the device will bear the costs for disassembly, transpor‐
tation and packaging.
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Instructions for use DIAGNOcam 2170
2 Safety | 2.5 Safety instructions
International (EU)
For country-specific information on disposal, contact your dental supplier.
2.5 Safety instructions
WARNING
Danger of injury from electric current.
Electric shock.
▶ Stop working if the device becomes damaged.
▶ Connect the device only to a PC/laptop that is approved according to IEC
60950.
▶ Do not use the device on patients or place it near patients with the probe re‐
moved.
▶ 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!
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Instructions for use DIAGNOcam 2170
2 Safety | 2.5 Safety instructions
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!
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.
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Instructions for use DIAGNOcam 2170
3 Product description | 3.1 System components
3 Product description
3.1 System components
3.1.1 Handpiece
① Window for camera lens system ③ Contact surface for the ring switch
② Aperture for the laser ④ Forked light barriers for probe iden‐
tification
3.1.2 Handpiece with attached tip
① Occlusal tip ④ Control button 2
② Ring switch ⑤ Handpiece
③ Control button 1 ⑥ USB 2.0 cable with anti-kink sleeve
and DC/DC voltage transformer
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Instructions for use DIAGNOcam 2170
3 Product description | 3.1 System components
3.1.3 Occlusal tip (Tip large, Tip small)
① Opening for camera window
① Aperture for laser beam
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Instructions for use DIAGNOcam 2170
3 Product description | 3.2 Operating buttons and ring switch
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 ③ Function
Briefly when the device is turned off Laser and camera turn on
(= the device is ready to use)
Briefly when the device is turned on Create still images that are automatical‐
ly saved
Long Laser and camera are being turned off
Actuation Control button 1 ④ Function
Brief Select the next tooth in the tooth dia‐
gram (in a clockwise direction)
Long Quick run through of the tooth diagram
(clockwise)
Actuation Control button 2 ⑤ Function
Brief Select the next tooth in the tooth dia‐
gram (anticlockwise direction)
Long Quick run through of the tooth diagram
(in an anticlockwise)
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Instructions for use DIAGNOcam 2170
3 Product description | 3.3 IDs and labels
3.3 IDs and labels
3.3.1 Rating plate
① Rating plate
Type Device type DIAGNOcam – Month produced/year produced
REF Material number
SN Serial number
Note: please note accompanying documents!
Classification (application part type BF)
CE mark according to 93/42/EEC medical devices
Labelling according to 2002/96/EC
Follow the Instructions for use
3.4 Technical Specifications
Complete system
Power consumption: max. 0.5 A
Supply voltage 5 V
Hose length 2.5 m
Weight 190 g
Protection class IP 44
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Instructions for use DIAGNOcam 2170
3 Product description | 3.4 Technical Specifications
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
Wavelength 780 nm
Opt. power 15 mW
opt. power according to DIN EN
60825-1 downstream of the occlusal
tips
max. 1 mW
Optical system
Image angle 105°
Viewing direction 80°
Focusing distance 4.5 mm
Operating conditions
Ambient temperature +10 to + 30° C
Air pressure 800 to 1060 hPa
Rel. humidity 5 to 95% non-condensing
Max. elevation for operation max. 2000 m
Storage and transportation conditions
Ambient temperature -10 to +55 °C
Air pressure 700 to 1060 hPa
Rel. humidity 5 to 95% non-condensing
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Instructions for use DIAGNOcam 2170
4 First use | 4.1 Hardware requirements
4 First use
4.1 Hardware requirements
▶ Connect the device only to a PC/laptop that is approved according to IEC
60950.
The system requirements are as follows:
▪ PC with at least 1 GHz processor power
▪ 256 MB RAM for single-user station or workstation
▪ 512 MB RAM for SQL database server
▪ 50 MB free hard disk space on system drive
▪ Depending on data volume, 5 to 50 GB hard disk space on the data drive
(may tally with system drive)
▪ Min. screen resolution 1024x768, min. colour depth 32 bits
▪ Operating system: Microsoft Windows XP, from Service Pack 3
Note
Windows Media Player 11 with express settings must be installed and have been
started once.
Please make sure to comply with the system requirements of other software and
hardware systems to be run in conjunction with KiD!
4.2 Software installation
Using the KaVo Integrated Desktop (KiD)
It is recommended to use the DIAGNOcam in combination with the KaVo KiD
software.
The software offers comfortable options for
▪ Recording images
▪ Evaluating images
▪ Image processing
▪ Archiving the images with a tooth diagram for each patient
4.2.1 Start the installation routine
▶ Insert the DIAGNOcam CD in the disk drive
▶ Double click the file, DIAGNOcam.... .exe in the root directory of the CD.
This starts the installation.
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Instructions for use DIAGNOcam 2170
4 First use | 4.2 Software installation
4.2.2 Installing a single-user system
▶ Click on "Next" in the setup start window to start the installation.
▶ Read the license agreements and select the option "I accept the agreements",
and click "Next".
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Instructions for use DIAGNOcam 2170
4 First use | 4.2 Software installation
▶ Select the target folder for the program directory, and click "Next".
Note
The program files are saved to the target directory. The target directory must be
on a local hard disk. It is recommended to use the suggested directory path (C:
\Programs\KaVo\KiD). A target directory on a network drive can cause malfunc‐
tions.
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Instructions for use DIAGNOcam 2170
4 First use | 4.2 Software installation
▶ Define the document directory
▶ Continue the installation
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Instructions for use DIAGNOcam 2170
4 First use | 4.2 Software installation
▶ Complete the installation clicking on Finish.
▶ Select the language (German or English)
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Instructions for use DIAGNOcam 2170
4 First use | 4.2 Software installation
▶ Click Next to install the drivers
▶ Program files are stored in the target directory.
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Instructions for use DIAGNOcam 2170
4 First use | 4.2 Software installation
▶ Click Install to install them
▶ Click Continue installation to install the software
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Instructions for use DIAGNOcam 2170
4 First use | 4.2 Software installation
▶ Click Continue installation to install the hardware
▶ Wait for the installation to be completed.
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Instructions for use DIAGNOcam 2170
4 First use | 4.2 Software installation
▶ It is recommended to re-start the computer
4.2.3 Installing a multiple-user system
When KiD is installed on a network, several workstations on which KiD is installed
can access a common database.
A computer in the network must be configured as the database server in this
case. This computer must always be booted up before all the other computers
and turned off after all other computers are turned off (for example in the evening
if at all).
Note
If you intend to install KiD on the network, the network server needs to be instal‐
led first.
Installing the network server
Note
In a multi-user system, all the associated workstations must access the same da‐
tabase server, the same database and the same document path; otherwise in‐
consistencies in the data can arise.
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Instructions for use DIAGNOcam 2170
4 First use | 4.2 Software installation
▶ Select "Network server" on the server.
▶ A database server can be installed without the KiD software. This is necessary
in case of a Windows 2000 server, since KiD does not support this system.
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Instructions for use DIAGNOcam 2170
4 First use | 4.2 Software installation
▶ When installing the database server or if the server release is not found, se‐
lect a document directory.
▶ Select Additional Tasks.
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Instructions for use DIAGNOcam 2170
4 First use | 4.2 Software installation
▶ Confirm the installation settings.
▶ Conclude installation.
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Instructions for use DIAGNOcam 2170
4 First use | 4.2 Software installation
KiD must first be installed on the database server in a multi-user system. Micro‐
soft SQL Server 2005 Express has to be installed only on this computer. The
checkbox must be deactivated at all other workstations.
Note
If Microsoft SQL Server is already installed on this computer, this version can be
used. The user account used for installation must have administrator rights.
Installing the network workstation
▶ Select the network workstation and click on Next
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Instructions for use DIAGNOcam 2170
4 First use | 4.2 Software installation
▶ Network is being scanned for SQL databases with authorisations
▶ Make the selection and click on Next
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Instructions for use DIAGNOcam 2170
4 First use | 4.2 Software installation
▶ Create a desktop icon and click on Next
▶ To install, click on Install
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Instructions for use DIAGNOcam 2170
4 First use | 4.2 Software installation
▶ Click on Finish to complete the installation
▶ Re-start the computer and click on Finish.
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Instructions for use DIAGNOcam 2170
4 First use | 4.2 Software installation
4.2.4 Installing a VDDS interface
▶ Start setup, click on Next
▶ Carry out the installation
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Instructions for use DIAGNOcam 2170
4 First use | 4.3 Remote maintenance by means of Netviewer
▶ Complete the installation
4.3 Remote maintenance by means of Netviewer
Service hotline:
+49 7351 56-2700
Service.Multimedia@kavo.com
Please indicate the product serial number in all requests.
Additional information can be obtained at: www.kavo.com
The remote service software, Netviewer, is installed automatically during installa‐
tion of KiD. Moreover, Netviewer can also be run by means of the Internet site:
support.kavo.com. You need to call the Technical Service by phone concurrently
to receive a session number.
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Instructions for use DIAGNOcam 2170
4 First use | 4.3 Remote maintenance by means of Netviewer
4.3.1 Starting Netviewer directly through button in KiD
▶ Press button for remote service
▶ Call our Technical Service (phone: +49 7351 56-2700) to request a session
number for Netviewer.
▶ Enter the session number and click on "Connect".
This starts up the remote service.
Note
The Technical Service can access the remote maintenance only if the customer
confirms the access. Access without confirmation is not feasible!
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Instructions for use DIAGNOcam 2170
4 First use | 4.3 Remote maintenance by means of Netviewer
▶ The Remote control window shows that the KaVo Service is connected to your
system.
▶ The Netviewer window was closed, click close to disconnect.
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Instructions for use DIAGNOcam 2170
5 Operation | 5.1 Attach and remove a tip
5 Operation
5.1 Attach and remove a tip
Slide the tip onto the handpiece
CAUTION
Attaching the tip misaligned
Damage to the unit
▶ When attaching the probe, make sure that the inner lug of the tip mates with
the opening in the forked light barriers.
Note
Tips must not be forced or twisted while attaching them!
Tips must be slid to the limit stop on the handpiece. Otherwise, areas within the
picture may remain covered.
▶ Evenly slide the tip to the stop. Make sure that the lug ① on the inside of the
tip mates with the opening in the forked light barriers.
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Instructions for use DIAGNOcam 2170
5 Operation | 5.1 Attach and remove a tip
Pulling the tip off the handpiece
Note
Tips must not be removed by being twisted.
Removing the tip, do not touch the control buttons.
▶ Pull the tip off the handpiece by applying a moderate amount of force; pull with
your left hand and push slightly with your right thumb. Do not touch the control
buttons.
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Instructions for use DIAGNOcam 2170
5 Operation | 5.2 Turning on/off
5.2 Turning on/off
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.
CAUTION
Product damage from misuse
Damage to the contacts
▶ Do not actuate the ring switch and control buttons when removing and
mounting the tips.
Note
An internal safety check is carried out automatically if no tip is attached: Each
time the device is used, upon inserting the USB plug in the computer, and when
the computer is turned on.
If a tip is attached when the handpiece is turned on, the safety check does not
run.
The laser light is not activated if there is no safety check. In this case, the tip
must be pulled off. The safety check then runs automatically.
Note
If the tip is removed during use, it deactivates the video picture and the illumina‐
tion. After attaching the tip again, the video image and illumination are turned on
again.
Start up
▶ Briefly press ring switch.
Switch off
Note
If no function key is pressed or if the tip is not changed over a period of 10 mi‐
nutes, the laser and camera are automatically shut off.
▶ Hold down the ring switch for 10 seconds.
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Instructions for use DIAGNOcam 2170
5 Operation | 5.3 Occlusal use
5.3 Occlusal use
CAUTION
Property damage from improper use
Damage to the light guide
▶ Do not kink the light guide in the flexible part of the probe.
Note
The live picture varies depending on the following factors:
– Type of tooth defect.
- Position of the feed surface.
– Type and position of tooth fillings.
The indication range includes premolar and molar teeth.
The occlusal probe comes with a spacer. For optimal high contrast images, the
spacer is to be placed on the neighbouring tooth. This way, light is fed through the
gingiva into the tooth and glare is avoided.
1
① Light aperture (inner)
Requirement
Professionally cleaned teeth.
▶ Attach the occlusal tip to the handpiece.
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Instructions for use DIAGNOcam 2170
5 Operation | 5.4 Brief instructions for the KiD
▶ Contact the light apertures ① to the gingiva.
▶ Place the spacer of the occlusal probe on the neighbouring tooth, and monitor
the live picture.
▶ Tip the probe slightly if needed.
▶ Use control buttons 2 and 3 to select the tooth in the tooth diagram for which a
picture will be saved.
▶ Press the ring switch to create a still picture and save it.
5.4 Brief instructions for the KiD
▶ Start the KiD.
▶ Create/select patients.
▶ Start the DIAGNOcam viewer.
▶ With the probe removed, connect the DIAGNOcam to the PC/laptop.
▶ Attach the probe.
▶ Briefly actuate the ring switch to turn on the laser and camera.
▶ Select the tooth in the tooth diagram using control buttons 2 and 3.
The selected tooth is shown dark blue.
▶ Create a freeze frame using the ring switch.
The freeze frame is assigned to the selected tooth in the tooth diagram.
Note
Teeth having assigned pictures are light blue in the tooth diagram.
▶ To switch to review mode, remove the probe and click on the "File Symbol" in
the live picture window.
▶ To return to KiD from viewer mode, click the red cross at the top right.
5.5 Determining findings and diagnosis
Note
Before the examination, the teeth must be clean. A professional tooth cleaning is
recommended.
Note
Carious changes are displayed as dark shades in contrast to the healthy tooth
substance.
Note
Residual cleaning agent, restoration material, calculus and discoloration on the
tooth surface can change the scatter of the light and hence also be displayed as
shade.
The dark shades in the picture may be interpreted as carious changes.
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Instructions for use DIAGNOcam 2170
5 Operation | 5.6 DIAGNOcam Function
▶ To secure the diagnosis, use additional diagnostic means such as the
DIAGNOdent pen 2190.
5.6 DIAGNOcam Function
Note
The software must always be closed, before unplugging the DIAGNOcam.
Start the DIAGNOcam
▶ Turn on the PC/laptop.
▶ Plug the DIAGNOcam without tip into the PC/laptop and wait until three
acoustical signals are emitted.
▶ Start-up the DIAGNOcam software.
Step 1:
▶ Select patient.
▶ Click on the "Select patient" field and open it.
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Instructions for use DIAGNOcam 2170
5 Operation | 5.6 DIAGNOcam Function
Step 2:
▶ Create patient.
▶ Click on the "Create new patient" symbol.
▶ Enter name of the patient and save it by clicking on the "OK" symbol.
Tool bar
Step 3:
▶ Select patient.
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Instructions for use DIAGNOcam 2170
5 Operation | 5.6 DIAGNOcam Function
▶ Double-click on patient name or confirm by clicking on "OK".
Step 4:
▶ Start-up the camera.
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Instructions for use DIAGNOcam 2170
5 Operation | 5.6 DIAGNOcam Function
▶ Firstly, click on the "DIAGNOcam" field and open it.
Start-up the recording mode
▶ Click on the "DIAGNOcam Live" field.
Step 5:
▶ Select tooth.
▶ Attach tip.
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Instructions for use DIAGNOcam 2170
5 Operation | 5.6 DIAGNOcam Function
Tooth scheme
Presentation Meaning
White tooth No images stored.
Light-blue tooth Images are stored for this tooth
Dark-blue tooth Currently selected tooth, stored images are shown in
the line below.
Note
The tooth number of the selected tooth in the tooth scheme (e.g. 47) is shown to
the left of the tooth scheme. If a tooth selected, only the images of the selected
tooth are displayed.
If no tooth is selected, an exclamation mark is shown instead of the tooth num‐
ber. All images recorded or images that are not assigned to a tooth are dis‐
played.
White exclamation marks: All recorded images are displayed.
Light-blue exclamation marks: Images that are not assigned to a tooth are dis‐
played.
Step 6:
▶ Trigger the exposure.
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Instructions for use DIAGNOcam 2170
5 Operation | 5.6 DIAGNOcam Function
▶ Position the DIAGNOcam accordingly on the tooth.
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Page 48
Instructions for use DIAGNOcam 2170
5 Operation | 5.6 DIAGNOcam Function
▶ Trigger the exposure by clicking on image 1 or actuating the ring switch ①.
▪ Image on top left: Current live image
▪ Image on right top and right in the middle: Most recently saved images
▶ In order to display an earlier image from the lower row in image 3, click on the
corresponding image in the lower row with the mouse to select it (blue
framed).
Icon Definition
▪ Ring switch is red: Disabled
▪ Ring switch is white: enabled
▪ Tooth selection <> red: disabled
▪ Tooth selection <> white: enabled
No tooth selected
Enable/disable video camera
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Instructions for use DIAGNOcam 2170
5 Operation | 5.6 DIAGNOcam Function
Setting brightness/contrast
▶ Select the "Options" field
We recommend using the default setting. If the teeth are displayed too brightly, it
may be advantageous to change the AEW values accordingly.
▶ Use "Default" to reset to factory settings
DIAGNOcam Review Mode
Images can viewed and compared in review mode.
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Instructions for use DIAGNOcam 2170
5 Operation | 5.6 DIAGNOcam Function
Start review mode from recording mode (DIAGNOcam video)
▶ Pull-off the tip.
▶ Click on the "Folder" symbol.
▶ Attach a tip to return to view mode.
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Instructions for use DIAGNOcam 2170
5 Operation | 5.6 DIAGNOcam Function
▶ Click on the "Ruler" symbol to measure a length in the image.
▶ Click on the "Ruler" symbol again to mark the length measurement in red. The
"Remove" button can be used to delete the length measurement marked in
red.
▶ Click on the "inverse" symbol to show an inverted display of the image.
▶ Click on "False colour" to display the image in false colours.
▶ Click on the "Tool bar" symbol to open or close the "Tool bar".
▶ Click on the "Original image" symbol to cancel any changes made.
▶ Click on the "Cancel" symbol to cancel the last change made.
▶ Click on the "Printer" symbol to print the image.
▶ Click on the "Delete" symbol to delete the image.
▶ Click on the "Export image" symbol to export the image.
Display recorded images of a tooth
▶ Select tooth 48 in the tooth scheme in the left bottom of the window by clicking
on it with the mouse.
The selected tooth (48) is shown dark blue.
The tooth number of the selected tooth (48) is shown to the left of the tooth
scheme.
The images assigned to the tooth are shown in the carousel in the middle and
bottom of the window.
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Instructions for use DIAGNOcam 2170
5 Operation | 5.6 DIAGNOcam Function
Display unassigned images
▶ In order to display all images that are not assigned to a tooth double-click on
the field showing the number "48".
A light-blue exclamation mark is shown to the left of the tooth scheme.
The images that are not assigned to a tooth are shown in the carousel in the
middle and bottom of the window.
Display all images
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Instructions for use DIAGNOcam 2170
5 Operation | 5.6 DIAGNOcam Function
▶ Click on exclamation mark to display all images (assigned and unassigned im‐
ages).
A white exclamation mark is shown to the left of the tooth scheme.
The images recorded (assigned and unassigned) are shown in the carousel in
the middle and bottom of the window.
Scrolling through images
▶ Click on the right top window region to display the active (front) image in the
carousel in the upper window region.
The selected window region on top is shown with a dark-blue frame.
▶ Use the navigation arrows to scroll forward or backward through the images in
the carousel.
Fixing images
▶ In order to fix an image in the selected window region, click on another win‐
dow region.
The selected window region on top is shown with a dark-blue frame.
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Instructions for use DIAGNOcam 2170
5 Operation | 5.6 DIAGNOcam Function
Comparing images
Images can be "fixed" in a window region on the top to allow them to be com‐
pared. You can then scroll through the images in another window region.
▶ Click on the window region, e.g. on the top right.
The "active" images in the carousel are displayed sequentially in the selected
window region.
The image stays "fixed" in the non-selected window region.
Enlarging/dividing an image
▶ Double-click on either one of the two window regions.
The two window regions on top are combined into a large one.
The image is shown at magnified scale.
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Instructions for use DIAGNOcam 2170
5 Operation | 5.6 DIAGNOcam Function
▶ Double-click on the large window region to divide the window region into two
windows.
The image is displayed reduced in size in the top left or right window region.
The previously displayed image is displayed in the respective other window
region.
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Instructions for use DIAGNOcam 2170
6 Reconditioning methods according to EN ISO 17664 | 6.1 Preparations for cleaning
6 Reconditioning methods according to EN ISO 17664
The listed instructions for cleaning and sterilising were validated as being suitable
by the medical device manufacturer for preparing a medical device. This usually
requires validation and routine monitoring of the procedure. Moreover, any devia‐
tion by the rehabilitating entity from the instructions provided should be carefully
analysed for impact on efficacy and possible consequences.
The following components must be reconditioned:
▪ Surface of the device
▪ Tips
CAUTION
Damage due to penetrating liquids.
Malfunctions from penetrated liquids.
▶ Do not allow any liquids to enter the device!
6.1 Preparations for cleaning
Note
The software must always be closed, before unplugging the DIAGNOcam.
▶ Remove tip.
6.2 Cleaning
Note
Do not use solvents or aggressive chemicals!
▶ Remove major soiling directly after soiling with a single-use paper towel.
6.3 Manual cleaning
▶ Clean all outer surfaces of the DIAGNOcam with a soft cloth and one of the
specified disinfectants.
▶ Clean the tips under running water (tap water quality, temperature: 30°C ±
5°C, flow rate: 2 l/min) for 30 seconds using a medium-hard toothbrush.
▶ If the window is soiled, clean it with isopropanol 70% and a Q-tip.
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Instructions for use DIAGNOcam 2170
6 Reconditioning methods according to EN ISO 17664 | 6.4 Machine cleaning
▶ Clean gently, since excessive force may damage the window.
6.4 Machine cleaning
Not applicable.
6.5 Disinfection
6.5.1 Manual disinfection
CAUTION
Product damage due to improper disinfection.
Malfunctions.
▶ Use disinfectant in accordance with the manufacturer's instructions!
▶ Perform wipe disinfection only!
▶ Do not immerse product in liquids
CAUTION
Material damage caused by spray disinfection.
▶ Do not subject the DIAGNOcam to spray disinfection.
KaVo recommends the following products based on material compatibility.
The microbiological efficacy must be ensured by the disinfectant manufacturer.
▪ Microcide AF made by Schülke&Mayr (liquid or cloths)
▪ Dürr FD322
▪ INCIDIN liquid
▪ Cavicide
For range of applications, please refer to the manufacturer's Instructions for Use.
▶ Wipe the surface of the DIAGNOcam and of the tips with a soft cloth and ap‐
proved disinfectants for disinfection.
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Instructions for use DIAGNOcam 2170
6 Reconditioning methods according to EN ISO 17664 | 6.6 Sterilisation
6.5.2 Automated disinfection
Not applicable.
6.6 Sterilisation
CAUTION
Product damage due to improper sterilisation
Damage to the sterilised object
▶ No hot air sterilisation, no chemical cold sterilisation, do not sterilise with eth‐
ylene oxide!
CAUTION
Moisture
Non-sterility
▶ Ensure dryness. Autoclaves with a after-vacuum ensure dryness! In addition,
drying can be accelerated through a 10 minute drying phase with the auto‐
clave door open.
Only the tips can be sterilised.
Sterilisation should directly follow cleaning.
Bag the tips prior to sterilisation.
The KaVo products released for sterilisation have a maximum temperature resist‐
ance of 138℃.
KaVo recommends, e.g.
- STERIclave B 2200/2200P made by KaVo
- Citomat/K-Serie made by Getinge
▶ Sterilising the probes in an autoclave:
Procedure Duration/Temperature
Autoclave three times with an initial
vacuum for
Autoclave using the gravitation method at least 10 minutes / 134°C ± 1°C
Store the tips in a bag
Note
When sterilising several handpieces in a single sterilisation cycle, do not exceed
the maximal load of the steriliser.
at least 3 minutes / 134°C ± 1°C
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Instructions for use DIAGNOcam 2170
6 Reconditioning methods according to EN ISO 17664 | 6.7 Control and functional checks
6.7 Control and functional checks
6.7.1 General
▶ Check for cleanliness.
6.7.2 Checking the tips
▶ Hold tips against a light source (e.g. daylight source) and check the optical fi‐
bres seen in the sleeve for contamination and defects.
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Instructions for use DIAGNOcam 2170
7 Troubleshooting
7 Troubleshooting
Note
If the DIAGNOcam is being unplugged while the software is still running, error
messages may be displayed at the next start-up. Always close the software be‐
fore unplugging the DIAGNOcam.
▶ If error messages are displayed at start-up, close all programs, and shut-down
and reboot the PC/laptop.
▶ Turn off the DIAGNOcam without delay if any malfunctions occur!
▶ Immediately notify your KaVo contact!
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Instructions for use DIAGNOcam 2170
8 Accessories
8 Accessories
1.005.1300 Tip large
1.005.1360 Tip small
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Instructions for use DIAGNOcam 2170
8 Accessories
1.005.1380 Holder DIAGNOcam
Additional accessories:
USB extension cable 3 m Mat. no. 1.005.1076
CD DIAGNOcam multi-user Mat. no. 1.009.6958
CD DIAGNOcam single-user Mat. no. 1.009.5110
CD VDDS plugin software Mat. no. 1.009.6960
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Instructions for use DIAGNOcam 2170
9 Data on electromagnetic compatibility according to EN 60601-1-2 | 9.1 Electromagnetic Transmissions
Measurements of emitted interfer‐
ence
HF emissions according to CISPR11Group 1 The DIAGNOcam 2170 device
HF emissions according to CISPR11Class B The DIAGNOcam 2170 device is
Emission of harmonics according
to EN 61000-3-2
Emission of voltage fluctuations/
flicker according to EN 61000-3-3
9 Data on electromagnetic compatibility according to EN 60601-1-2
9.1 Electromagnetic Transmissions
The DIAGNOcam 2170 device is designed for use in an environment as specified
below. The customer or the user of the DIAGNOcam 2170 should ensure that the
device is used in an environment of the specified type.
Conformance Electromagnetic environment -
Guidelines
uses HF energy for its internal
functions exclusively. Therefore,
the HF emission of the device is
very low and interference with ad‐
jacent electronic devices is unlike‐
ly.
suitable for use in all facilities in‐
cluding residential ones, and facili‐
ties that are directly connected to a
public power supply that also sup‐
plies residential buildings.
Class A The DIAGNOcam 2170 device is
suitable for use in all facilities in‐
cluding residential ones, and facili‐
ties that are directly connected to a
public power supply that also sup‐
plies residential buildings.
Conforms The DIAGNOcam 2170 device is
suitable for use in all facilities in‐
cluding residential ones, and facili‐
ties that are directly connected to a
public power supply that also sup‐
plies residential buildings.
9.2 Resistance to electromagnetic interference
The DIAGNOcam 2170 device is designed for use in an environment as specified
below. The customer or the user of the DIAGNOcam 2170 should ensure that the
device is used in an environment of the specified type.
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Instructions for use DIAGNOcam 2170
9 Data on electromagnetic compatibility according to EN 60601-1-2 | 9.3 Immunity to electromagnetic inter‐
ference
Interference immunity
tests
Electrostatic discharge
(ESD) according to EN
61000-4-2
Fast transient electrical
interference / bursts ac‐
cording to EN 61000-4-4
Surges according to EN
61000-4-5
Voltage interruptions,
short-term interruptions
and fluctuations of the
supply voltage according
to EN 61000-4-11
Magnetic field at a supply
frequency (50/60 Hz) ac‐
cording to EN 61000-4-8
EN 60601 test level Compliance level Electromagnetic environ‐
ment - Guidelines
± 6 kV contact discharge
± 8 kV atmospheric dis‐
charge
± 2/4/6 kV contact dis‐
charge
± 2/4/8 kV atmospheric
discharge
Floors should be made of
wood or concrete or be
fitted with ceramic tiles. If
the floor is fitted with syn‐
thetic material, the rela‐
tive humidity must be at
least 30%.
± 2 kV for power lines
± 1 kV for input and out‐
put lines
± 2 kV for power lines The quality of the supply
voltage should corre‐
spond to that of a typical
business or hospital
environment.
± 1 kV push-pull voltage
± 2 kV common mode
voltage
± 1 kV push-pull voltage
± 2 kV common mode
voltage
The quality of the supply
voltage should corre‐
spond to that of a typical
business or hospital
environment.
< 5% U
T
(> 95% interruption)
for ½ period
40 % U
T
(60% interruption)
for 5 periods
70 % U
T
(30% interruption)
for 25 periods
< 5% U
T
(> 95% interruption)
for 5 s
(250 periods)
< 5% U
T
(> 95% interruption)
for ½ period
40 % U
T
(60% interruption)
for 5 periods
70 % U
T
(30% interruption)
for 25 periods
< 5% U
T
(> 95% interruption)
for 5 s
(250 periods)
The quality of the supply
voltage should corre‐
spond to that of a typical
business or hospital envi‐
ronment. If the user
needs the DIAGNOcam
2170 to work even if the
power supply is interrup‐
ted, we recommend sup‐
plying energy to the DI‐
AGNOcam 2170 from an
uninterruptible power sup‐
ply or battery.
3 A/m 3 A/m Magnetic fields at the
mains frequency should
correspond to typical val‐
ues in a business and
hospital environment.
NOTE: V T is the alternating mains voltage before the test level is used.
9.3 Immunity to electromagnetic interference
The DIAGNOcam 2170 device is designed for use in an environment as specified
below. The customer or the user of the DIAGNOcam 2170 should ensure that the
device is used in an environment of the specified type.
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Instructions for use DIAGNOcam 2170
9 Data on electromagnetic compatibility according to EN 60601-1-2 | 9.3 Immunity to electromagnetic inter‐
ference
Interference immunity
tests
Wire-based HF inter‐
ference according to
EN 61000-4-6
Wireless HF interfer‐
ence according to EN
61000-4-3
EN 60601 test level Compliance level Electromagnetic environment -
Guidelines
3 V
eff
150 kHz to 80 MHz
outside the ISM bands
3 V/m
80 MHz to 2.5 GHz
3 V
3 V/m
a
eff
Handheld and mobile wireless de‐
vices should not be used at a
shorter distance from theDIAGNO‐
cam 2170 including cables than
the recommended safe clearance
calculated using the appropriate
equation for the emission frequen‐
cy.
Recommended safe distance:
d = 1.17
P
d= 1.17 Pfor 80 MHz to 800 MHz
d= 2.33 Pfor 800 MHz to 2.5 GHz
where P is the maximal nominal
power of the transmitter in watts
(W) as specified by the transmitter
manufacturer and d is the recom‐
mended safe clearance in metres
(m).
b
The field strength of stationary
wireless radio transmitters as
measured locallycshould be lower
than the conformance level at all
frequencies.
d
Interference is possible in the vi‐
cinity of devices bearing the fol‐
lowing icon.
NOTE 1: At 80 MHz and 800 MHz, the higher frequency range applies.
NOTE 2: These guidelines may not be applicable in every case. The spread of
electromagnetic waves is absorbed and reflected by buildings, objects and peo‐
ple.
a
The ISM frequency bands (for industrial, scientific, and medical applications) be‐
tween 150 kHZ and 80 MHz are 6.765 MHz to 6.795 MHz; 13.553 MHz to 13.567
MHz; 26.957 MHz to 27.283 MHz, and 40.66 MHz to 40.70 MHz.
b
The compliance levels in the ISM frequency bands between 150 kHz and 80
MHz and in the frequency range from 80 MHz to 2.5 GHz are intended to reduce
the probability of mobile/handheld communications facilities causing interference
when they are inadvertently introduced into the patient area. For this reason, the
additional factor of 10/3 is applied in the calculation of the recommended safe
clearances in these ranges of frequencies.
c
The field strength of stationary transmitters, such as, e.g. base stations of mobile
phones and mobile terrestrial radio devices, amateur radio stations, AM and FM
radio and television transmitters, cannot be determined exactly based on theoreti‐
cal considerations. A site study should be considered to determine the electro‐
magnetic environment in terms of stationary transmitters. If the measured field
strength at the site, at which the DIAGNOcam 2170 is used, exceeds the compli‐
ance levels shown above, the DIAGNOcam 2170 should be monitored to demon‐
strate proper function. If any uncommon performance characteristics are ob‐
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Instructions for use DIAGNOcam 2170
9 Data on electromagnetic compatibility according to EN 60601-1-2 | 9.4 Recommended safe distance be‐
tween portable and mobile HF telecommunications equipment and the treatment unit
served, additional measures may be required, such as, e.g., changing the orienta‐
tion or using a different location for the DIAGNOcam 2170.
d
In the frequency range of 150 kHz to 80 MHz, the field strength should be less
than 3V
V/m.
eff
9.4 Recommended safe distance between portable and mobile HF telecommunications equipment and the treatment unit
Rated power of the trans‐
mitter in W
0.01 0.1 0.1 0.2
0.1 0.4 0.4 0.7
1 1.2 1.2 2.3
10 3.7 3.7 7.4
100 11.7 11.7 23.3
The DIAGNOcam 2170 is intended for use in an electromagnetic environment in
which the HF interference parameters are controlled. The customer or the user of
the DIAGNOcam 2170 can help prevent electromagnetic interference by main‐
taining the minimum distance between portable and mobile HF telecommunica‐
tions devices (transmitters) and the DIAGNOcam 2170 depending on the output
of the communication device as indicated below.
Safe distance depending on the transmission frequency:
150 kHz to 80 MHz
d=1.17P m
80 MHz to 800 MHz
d=1.17P m
800 MHz to 2.5 GHz
d=2.33P m
For transmitters whose maximum rated power is not in the above table, the rec‐
ommended safe distance d in meters (m) can be calculated using the equation for
the respective gap, where P is the maximum rated power of the transmitter in
Watts (W) according to the manufacturer's information.
NOTE 1: At 80 MHz and 800 MHz, the higher frequency range applies.
NOTE 2: These guidelines may not be applicable in every case. The spread of
electromagnetic waves is absorbed and reflected by buildings, objects and peo‐
ple.
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1.006.3964 · Fk · 20120823 - 04 · en
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