KaVo DIAGNOdent 2190 User manual

Instructions for use
DIAGNOdent pen 2190
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
1User instructions............................................................................................................................................... 5
1.1 User guide................................................................................................................................................ 5
1.1.1 Abbreviations............................................................................................................................... 5
1.1.2 Symbols....................................................................................................................................... 5
1.1.3 Target group................................................................................................................................ 6
1.2 Service...................................................................................................................................................... 6
1.3 Warranty terms and conditions................................................................................................................. 6
1.4 Transportation and storage....................................................................................................................... 6
1.4.1 Currently valid packaging regulations......................................................................................... 6
1.4.2 Damage in transit........................................................................................................................ 7
1.4.3 Information on the packaging: Storage and transportation......................................................... 8
2Safety............................................................................................................................................................... 9
2.1 Description of safety instructions.............................................................................................................. 9
2.1.1 Warning symbol........................................................................................................................... 9
2.1.2 Structure...................................................................................................................................... 9
2.1.3 Description of hazard levels........................................................................................................ 9
2.2 Safety instructions.................................................................................................................................... 9
2.2.1 Product-specific........................................................................................................................... 9
2.2.2 Protective equipment................................................................................................................. 10
2.3 Electromagnetic compatibility................................................................................................................. 11
2.4 Disposal.................................................................................................................................................. 11
2.5 Disposal of electronic and electrical devices.......................................................................................... 11
3Product description......................................................................................................................................... 13
3.1 DIAGNOdent pen 2190........................................................................................................................... 13
3.2 Purpose – Proper use............................................................................................................................. 14
3.2.1 General...................................................................................................................................... 14
3.2.2 Product-specific......................................................................................................................... 15
3.3 Rating plate............................................................................................................................................. 16
3.4 Technical Specifications......................................................................................................................... 17
4First use.......................................................................................................................................................... 18
4.1 Insert the battery..................................................................................................................................... 18
5Operation........................................................................................................................................................ 20
5.1 Mode of operation of the DIAGNOdent pen 2190................................................................................... 20
5.2 Inserting the probe.................................................................................................................................. 20
5.3 Turning on/off.......................................................................................................................................... 21
5.3.1 Start up...................................................................................................................................... 21
5.3.2 Switch off................................................................................................................................... 21
5.4 Menus..................................................................................................................................................... 21
5.4.1 Select probe memory................................................................................................................ 21
5.4.2 Checking/setting the reference value........................................................................................ 22
5.4.3 Calibrating the probes with a reference..................................................................................... 22
5.4.4 Setting the volume..................................................................................................................... 24
5.4.5 Turning infrared data transmission on and off........................................................................... 24
5.5 Determine findings.................................................................................................................................. 25
5.5.1 General...................................................................................................................................... 25
Instructions for use DIAGNOdent pen 2190
Table of contents
3 / 44

5.5.2 Procedure.................................................................................................................................. 26
5.5.3 Individually adjust the DIAGNOdent pen 2190 to the patient.................................................... 26
5.5.4 Scanning the tooth surface........................................................................................................ 28
5.5.5 Detect concretions and calculus with the paro probe (optional accessory)............................... 30
6Maintenance................................................................................................................................................... 33
6.1 Setup methods according to DIN EN ISO 17664.................................................................................... 33
6.1.1 Preparations for cleaning........................................................................................................... 34
6.1.2 Cleaning.................................................................................................................................... 34
6.1.3 Disinfection................................................................................................................................ 34
6.1.4 Sterilization in a steam sterilizer in compliance with DIN EN 13060......................................... 35
6.1.5 Control and function test............................................................................................................ 35
6.1.6 Packaging and storage.............................................................................................................. 36
7Troubleshooting.............................................................................................................................................. 37
8Accessories.................................................................................................................................................... 38
9Information on electromagnetic compatibility................................................................................................. 39
Instructions for use DIAGNOdent pen 2190
Table of contents
4 / 44

Instructions for use DIAGNOdent pen 2190
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
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
RK Retrofitting kit
AS Assembly set
EP Enclosed parts
EMC Electromagnetic compatibility
PI Processing instructions
1.1.2 Symbols
Refer to the chapter on Safety/Warning symbol
Important information for users and service technicians
Thermodisinfectable
Suitable for steam sterilisation at up to 138 °C
CE mark (European Community). A product bearing this mark meets the re‐
quirements of the pertinent EC directives, i.e. the standards applicable in Eu‐
rope.
Action request
Laser warning sign hazard symbol
Laser notification sign, classified in accordance with IEC 60825:2007
5 / 44

Instructions for use DIAGNOdent pen 2190
1 User instructions | 1.2 Service
6 / 44
1.1.3 Target group
This document is for dentists and dental office staff.
1.2 Service
Please direct all questions regarding the product, service, and maintenance to the fol‐
lowing addresses.
Please refer to the serial number of the product in all inquiries!
Service-Hotline:
[phone]
[email protected]
For further information, please visit: www.kavo.com
KaVo Dental GmbH
Customer Service Center
Bahnhofstraße 20
D-88445 Warthausen
[phone]
www.kavo.com
1.3 Warranty terms and conditions
Within the scope of the applicable KaVo delivery and payment conditions, KaVo guar‐
antees proper function, absence of defects in material and workmanship for a period
of 12 months from the date of purchase as confirmed by the salesperson.
In case of justified complaints, KaVo will honour its warranty with a free replacement
or repair.
The warranty does not cover defects and their consequences that arose or may have
arisen due to natural wear, improper handling, cleaning or maintenance, non-compli‐
ance with operating, maintenance or connection instructions, corrosion, contaminated
media supply or chemical or electrical influences deemed abnormal or impermissible
in accordance with factory specifications.
The warranty does not usually cover lamps, light conductors made of glass and glass
fibres, glassware, rubber parts and the colourfastness of plastic parts.
The warranty expires if defects or their consequences could possibly have arisen be‐
cause the product has been modified or changed. Warranty claims can only be asser‐
ted when they are immediately reported to KaVo in writing.
This notification must be accompanied by a copy of the invoice or delivery note on
which the manufacturing number is clearly visible. In addition to the guaranty, the stat‐
utory warranty claims of the purchaser also apply with a warranty period of 12 months.
1.4 Transportation and storage
1.4.1 Currently valid packaging regulations
Note
Only valid for the Federal Republic of Germany.

Instructions for use DIAGNOdent pen 2190
1 User instructions | 1.4 Transportation and storage
Dispose of and recycle the sales packaging appropriately in accordance with current
packaging regulations, employing waste management or recycling companies. Com‐
ply with the comprehensive return system. KaVo has had its sales packaging licensed
for this purpose. Please comply with the regional public waste-disposal system.
1.4.2 Damage in transit
In Germany
If the packaging is visibly damaged on delivery, please proceed as follows:
1. The recipient of the package must record the loss or damage on the delivery re‐
ceipt. The recipient and the representative of the shipping company must sign this
delivery receipt.
2. Leave the product and packaging in the condition in which you received it.
3. Do not use the product.
4. Report the damage to the shipping company.
5. Report the damage to KaVo.
6. Consult with KaVo first, before returning a damaged product.
7. Send the signed delivery receipt to KaVo.
If the product is damaged but there was no discernable damage to the packaging
upon delivery, proceed as follows:
1. Report the damage to the shipping company immediately and no later than 7 days
after delivery.
2. Report the damage to KaVo.
3. Leave the product and packaging in the condition in which you received it.
4. Do not use a damaged product.
Note
If the recipient fails to comply with any of the above-mentioned obligations, the
damage will be considered to have arisen after delivery
(in accordance with the General German Freight Forwarders´ Terms and Conditions, Art. 28)
.
Outside Germany
Note
KaVo shall not be held liable for damage arising from transportation.
The shipment must be checked on arrival.
If the packaging is visibly damaged on delivery, please proceed as follows:
1. The recipient of the package must record the loss or damage on the delivery re‐
ceipt. The recipient and the representative of the shipping company must sign this
delivery receipt.
Without this evidence, the recipient will not be able to assert a claim for damages
against the shipping company.
2. Leave the product and packaging in the condition in which you received it.
3. Do not use the product.
If the product is damaged but there was no discernable damage to the packaging
upon delivery, proceed as follows:
1. Report any damage to the shipping company either immediately or no later than 7
days after delivery.
2. Leave the product and packaging in the condition in which you received it.
3. Do not use a damaged product.
7 / 44

Instructions for use DIAGNOdent pen 2190
1 User instructions | 1.4 Transportation and storage
8 / 44
Note
If the recipient fails to comply with any of the above-mentioned obligations, the
damage will be considered to have arisen after delivery
(in accordance with CMR law, Chapter 5, Art. 30).
1.4.3 Information on the packaging: Storage and transportation
Note
Please keep the packaging in case you need to return the product for servicing or
repair.
The symbols printed on the outside are for transportation and storage, and have the
following meaning:
Transport upright with the arrows pointing upwards!
Fragile - protect against impact!
Protect from moisture!
Permissible stacking load
Temperature range
Humidity
Air pressure

Instructions for use DIAGNOdent pen 2190
2 Safety | 2.1 Description of safety instructions
2 Safety
2.1 Description of safety instructions
2.1.1 Warning symbol
Warning symbol
2.1.2 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.
2.1.3 Description of hazard levels
Safety instructions distinguishing between three hazard levels are used in this docu‐
ment to prevent personal and property damage.
CAUTION
CAUTION
indicates a hazardous situation that can cause damage to property or mild to moder‐
ate 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.
2.2 Safety instructions
2.2.1 Product-specific
CAUTION
Injury/damage due to leaky battery.
Health damage and product damage.
▶ Use leak-proof batteries only!
▶ Remove the battery during long downtimes!
▶ Properly dispose of used batteries!
▶ Do not use rechargeable batteries!
▶ Do not touch battery contacts and patient at the same time!
9 / 44

Instructions for use DIAGNOdent pen 2190
2 Safety | 2.2 Safety instructions
10 / 44
CAUTION
Danger of injury from electric current
Electrical shock
▶ Do not use power supplies.
▶ Only supply the product with the specified voltage.
CAUTION
Hazard from improper use.
Injury and damage.
▶ The product may only be used by trained professionals.
CAUTION
Risks from electromagnetic fields.
Electromagnetic fields might interfere with the functions of implanted systems (such
as pacemakers).
▶ Ask patients if they have a cardiac pacemaker or other system implanted before
you start the treatment!
CAUTION
Blinding hazard from laser beam of laser class 1.
Eye injury.
▶ Do not look into the laser beam!
▶ Do not open the unit.
WARNING
Aspiration of the probe.
Danger of suffocation.
▶ Check the seating of the probe in the DIAGNOdent pen 2190 by pulling on it!
CAUTION
Leaky LCD.
Harmful to health.
▶ Turn off the unit when the LCD is damaged.
▶ Do not contact the liquid.
▶ In case of contact with liquid, immediately rinse with water.
▶ Consult a physician if any symptoms are manifested.
2.2.2 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.

Instructions for use DIAGNOdent pen 2190
2 Safety | 2.3 Electromagnetic compatibility
2.3 Electromagnetic compatibility
Note
Based on DIN EN 60601-1-2 concerning the electromagnetic compatibility of elec‐
tromedical devices, we need to point out that:
• Medical electrical devices are subject to special measures regarding electromag‐
netic compatibility and must be operated in accordance with the requirements listed
below.
• Portable and mobile high-frequency communications devices can influence medi‐
cal electronics.
Note
KaVo cannot guarantee the compliance of accessories, cables, and other compo‐
nents not supplied by KaVo with the EMC requirements of IEC 60601-1-2 (DIN EN
60601-1-2).
See also:
29 Information about electromagnetic compatibility, Page 39
2.4 Disposal
Note
Any waste which is generated must be recycled or disposed of in strict compliance
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.
2.5 Disposal of electronic and electrical devices
Note
According to EC directive 2002/96 concerning used electrical and electronic devi‐
ces, this product is subject to the cited directive and must be disposed of according‐
ly within Europe.
For more information, please visit www.kavo.com or contact your specialised dental
supplier.
For final disposal, please contact:
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 com‐
plete it as an online order.
2. Enter the corresponding information to complete the order, and submit it as an on‐
line order or by fax [phone] to enretec GmbH.
The following contact options are also available for questions and for initiating a
disposal order:
Phone: [phone]
Email: [email protected] and
Postal address: enretec GmbH, Geschäftsbereich eomRECYCLING®
Kanalstraße 17
D-16727 Velten
11 / 44

Instructions for use DIAGNOdent pen 2190
2 Safety | 2.5 Disposal of electronic and electrical devices
12 / 44
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, trans‐
portation and packaging.
International
For country-specific information on disposal, contact your dental supplier.

Instructions for use DIAGNOdent pen 2190
3 Product description | 3.1 DIAGNOdent pen 2190
3 Product description
3.1 DIAGNOdent pen 2190
14
1
12
11
2 4 5 6 7 8
10
13
3 9
16
15
17
18
①Ring switch ②The start button
③Warning sign: danger, laser ④Save button
⑤Minus button ⑥Plus button
⑦Menu button ⑧LCD display
⑨Laser notification sign ⑩Battery compartment
⑪Rating plate ⑫Grip sleeve
⑬Fissure probe ⑭Prox probe
⑮Paro probe (optional accessory) ⑯Guide to prox probe
⑰Standard C with holder ⑱Special holder for Steribox
13 / 44

Instructions for use DIAGNOdent pen 2190
3 Product description | 3.2 Purpose – Proper use
14 / 44
①Laser beam exit ②Infrared beam exits at the black end
cap
③Reference value menu ④Symbol for infrared data transmission
⑤Volume menu ⑥Probe memory menu
⑦MOMENT display ⑧PEAK display
⑨Calibration ⑩Battery warning symbol
⑪Probe memory (1-4)
3.2 Purpose – Proper use
3.2.1 General
The overarching guidelines and/or national laws, national regulations and the rules of
technology applicable to the startup and use of the KaVo product for the intended pur‐
pose are to be applied and complied with.
This KaVo product is intended only for use in the field of dentistry. The product may
not be used for a purpose for which it was not intended.
"Proper use" includes following all the instructions for use and ensuring that all inspec‐
tions and service tasks are performed.
Manipulations of the unit modifying it from its original condition are not permissible.
The use of this KaVo product is not permitted in areas subject to an explosion hazard.

Instructions for use DIAGNOdent pen 2190
3 Product description | 3.2 Purpose – Proper use
The user must ensure that the unit works properly and is in satisfactory condition be‐
fore each use.
The applicable national legal regulations must be observed during the use of the de‐
vice, in particular the following:
▪ Applicable regulations governing the connection and start-up of medical devices.
▪ Current occupational safety regulations.
▪ Current 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
In Germany, operators, equipment managers and users are obliged to operate their
equipment in accordance with the MPG regulations.
The services encompass all the test tasks required in accordance with § 6 of the medi‐
cal devices operator ordinance (Medizinprodukte-Betreiberverordnung, MPBetreibV).
3.2.2 Product-specific
The DIAGNOdent pen 2190 is only for dental treatment within the context of dental
medicine. It is to be used in a dentist's office or dental clinic.
The DIAGNOdent pen 2190 is a tool that helps dentist's detect concretions or caries in
teeth that have been thoroughly cleaned.
The tooth substance is caused to fluoresce with a laser light. The DIAGNOdent pen
2190 recognises this fluorescence and the differences between healthy and diseased
tooth substance is displayed by the DIAGNOdent pen 2190.
By using the installed infrared diodes, you can show the display values of the DIAG‐
NOdent pen 2190 on the DIAGNOdent display 2191 to inform the patient. Further in‐
formation can be found in the instructions for use of the DIAGNOdent display 2191.
The DIAGNOdent pen 2190 meets laser class 1 according to IEC 60825-1:2007.
The DIAGNOdent pen 2190 is a class IIa medical device according to EC Directive
93/42/EEC and meets the requirements of 2004/108/EC, etc. in regard to electromag‐
netic compatibility.
The following persons are authorised to repair and service the KaVo product:
▪ Technicians of KaVo branch offices after appropriate product training.
▪ Specifically KaVo-trained technicians of KaVo franchised dealers.
Safety checks are not necessary.
15 / 44

Instructions for use DIAGNOdent pen 2190
3 Product description | 3.3 Rating plate
16 / 44
3.3 Rating plate
CE mark
CSA mark
Classification (applied part type B)
For disposal information, see Intended use
Follow the instructions for use, icon is attached on the side of the unit
Manufacturer
+
Battery name
MM Month manufactured
YYYY Year manufactured
SN ???
????
Sequential SN
REF Material number
Type: Device type
IP 44 Degree of protection against ingress of solid and liquid substances

Instructions for use DIAGNOdent pen 2190
3 Product description | 3.4 Technical Specifications
3.4 Technical Specifications
Length approximately 220 mm
Diameter approximately 32 mm
Weight 110 g
Voltage
1 cell, mignon LR6 alkaline
1.5 V
Light output of the laser diode <1 mW
Wavelength of the laser diode 655 nm
Beam strength of the infrared diode <140mW/sr
Wavelength of the infrared diode 850 nm - 950 nm
Degree of protection IP 44
Operating temperature +10 oC to +30 oC
Calibration temperature +22oC ±2oC
relative humidity 30% RH to 75% RH
Power consumption <200 mA
Transportation and storage conditions
Transportation and storage temperature -10 oC to +55 oC
relative humidity 5% RH to 90% RH
Air pressure 700 hPa to 1060 hPa
17 / 44

Instructions for use DIAGNOdent pen 2190
4 First use | 4.1 Insert the battery
18 / 44
4 First use
CAUTION
Non-sterile gripping sleeve and probes.
Health damage.
▶ Sterilise the probes and gripping sleeves before first startup since they are deliv‐
ered in non-sterile condition by the manufacturer!
See also:
26.1 Reprocessing methods according to DIN EN ISO 17664, Page 33
4.1 Insert the battery
CAUTION
Injury/damage due to leaky battery.
Health damage and product damage.
▶ Use leak-proof batteries only!
▶ Remove the battery during long downtimes!
▶ Properly dispose of used batteries!
▶ Do not use rechargeable batteries!
▶ Do not touch battery contacts and patient at the same time!
Note
Only use the type mignon LR6 alkaline cell.
CAUTION
Product damage from misuse.
Damage to the contacts.
▶ Do not turn on the ring switch ① when removing and shoving on the grip
sleeve②.
▶ Remove the grip sleeve
1
2

Instructions for use DIAGNOdent pen 2190
4 First use | 4.1 Insert the battery
▶ Insert conventional mignon (LR6) alkaline cell matching the polarity ③.
1
2
3
▶ Shove on the grip sleeve
19 / 44

Instructions for use DIAGNOdent pen 2190
5 Operation | 5.1 Mode of operation of the DIAGNOdent pen 2190
20 / 44
5 Operation
5.1 Mode of operation of the DIAGNOdent pen 2190
Changed tooth substance emits fluorescent radiation when exposed to light of a cer‐
tain wavelength. This radiation is detected and analysed.
A specific amount of light energy is supplied by the light probe that contacts and en‐
ters the tooth surface. If fluorescent light arises in the case of a pathological change, it
is evaluated.
At a fissure, careful scanning is required since this allows very small defects to be de‐
tected. By moving the probe slightly back and forth over the base of the fissure, the
detection sensitivity can be increased and the location of maximum florescence can
be identified.
5.2 Inserting the probe
▶ Insert the probe until it snaps into place.
WARNING
Aspiration of the probe.
Danger of suffocation.
▶ Check the seating of the probe in the DIAGNOdent pen 2190 by pulling on it!