KaVo DIAGNOcam 2170 User manual

Instructions for use
DIAGNOcam 2170
Always be on the safe side.

Distributed by:
KaVo Dental GmbH
Bismarckring 39
D-88400 Biberach
Phone [phone]
Fax [phone]
Manufacturer:
Kaltenbach & Voigt GmbH
Bismarckring 39
D-88400 Biberach
www.kavo.com

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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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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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
Explanation
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
1.1.2 Symbols
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
1.1.3 Target group
This document is for dentists and dental office staff.
1.1.4 Service
Service hotline:
[phone]
[email protected]
Please indicate the product serial number in all requests.
Additional information can be obtained at: www.kavo.com
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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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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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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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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 [phone]) to enretec GmbH.
The following avenues are also available for questions and for initiating a dis‐
posal request:
Telephone: [phone]
E-mail: [email protected] 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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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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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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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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3.1.3 Occlusal tip (Tip large, Tip small)
① Opening for camera window
① Aperture for laser beam
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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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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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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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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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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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▶ 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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▶ Define the document directory
▶ Continue the installation
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