KaVo DIAGNOdent 2191 User manual

Instructions for use
DIAGNOdent display 2191

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

Instructions for use DIAGNOdent display 2191
Table of contents
3 / 32
Table of contents
1 User instructions ............................................................................................................... 4
2 Safety................................................................................................................................. 6
2.1 Infection hazard ............................................................................................................ 6
2.2 Explosion hazard ........................................................................................................... 6
2.3 Technical condition ........................................................................................................ 6
2.4 Electromagnetic fields .................................................................................................... 7
2.5 Accessories and combination with other equipment........................................................... 7
2.6 Qualification of personnel ............................................................................................... 7
2.7 Service and repair ......................................................................................................... 7
2.8 Disposal........................................................................................................................ 8
3 Description of the product................................................................................................. 9
3.1 DIAGNOdent display 2191 .............................................................................................. 9
3.2 Intended use................................................................................................................. 10
3.3 Symbols on product, packaging and rating plate ............................................................... 11
3.4 Technical Specifications.................................................................................................. 13
3.5 Transportation and storage conditions ............................................................................. 13
3.5.1 Damage in transit............................................................................................. 14
4 Startup............................................................................................................................... 15
4.1 Insert batteries.............................................................................................................. 15
5 Operation........................................................................................................................... 18
5.1 Start up........................................................................................................................ 18
5.2 Turn off ........................................................................................................................ 19
5.3 Display brightness ......................................................................................................... 21
5.4 Volume......................................................................................................................... 21
5.5 Battery charge display.................................................................................................... 22
5.6 Reception quality........................................................................................................... 22
5.7 Bar display of MOMENT and PEAK value ........................................................................... 23
6 Maintenance ...................................................................................................................... 24
7 Reprocessing steps in accordance with ISO 17664-1 / ISO 17664-2 .............................. 25
7.1 Preparations at the site of use......................................................................................... 25
7.2 Manual Reprocessing ..................................................................................................... 25
7.2.1 Manual external cleaning................................................................................... 25
7.2.2 Manual internal cleaning.................................................................................... 25
7.2.3 Manual external disinfection .............................................................................. 25
7.2.4 Manual internal disinfection ............................................................................... 26
7.2.5 Manual drying .................................................................................................. 26
7.3 Automated reprocessing................................................................................................. 26
7.4 Sterilisation................................................................................................................... 26
8 Troubleshooting ................................................................................................................ 27
9 Disposal ............................................................................................................................. 28
10Information about electromagnetic compatibility ............................................................ 29
10.1 Operating environment and EMC warning notes................................................................ 29
10.2 Results of the electromagnetic tests ................................................................................ 29
11Terms and conditions of warranty .................................................................................... 31

Instructions for use DIAGNOdent display 2191
1 User instructions
4 / 32
1 User instructions
Dear user,
Congratulations on purchasing this KaVo quality product. By following the notes
below you will be able to work smoothly, economically and safely.
© Copyright by KaVo Dental GmbH
KaVo and DIAGNOdent are either registered trademarks or trademarks of KaVo
Dental GmbH.
All other trademarks are property of their respective owners.
KaVo Original Factory Repair
In the event of a repair, please ship your product to the KaVo Original Factory
Repair using www.kavobox.com.
KaVo Technical Service
If you have any technical questions or complaints, please contact the KaVo
Technical Service:
[phone]
[e-mail]
Target group
The instructions for use are intended for medical professionals, in particular
dentists and dental practice personnel.
Abbreviations
LCD Liquid Crystal Display
IEC International Electrotechnical Commission
EMC Electromagnetic compatibility
General marks and symbols
See Chapter on User Instructions/Hazard Levels
Important information for users and service technicians
Action request
Non-sterilisable
Laser warning sign hazard symbol
Laser notification sign, classified in accordance with IEC 60825-1
Original language German

Instructions for use DIAGNOdent display 2191
1 User instructions
5 / 32
Hazard levels
The warning and safety notes in this document must be observed to prevent
personal injury and material damage. The warning notes are designated as
shown below:
HAZARD
In cases which – if not prevented – directly lead to death or severe injury.
WARNING
In cases which – if not prevented – can lead to death or severe injury.
CAUTION
In cases which – if not prevented – can lead to minor or moderate injury.
CAUTION
In cases which – if not prevented – can lead to material damage.

Instructions for use DIAGNOdent display 2191
2 Safety | 2.1 Infection hazard
6 / 32
2 Safety
NOTE
All serious events occurring in relation to the product must be reported to the
manufacturer and the competent authority of the member state, in which the
user and/or patient resides.
The instructions for use are an integral part of the product and must be read
carefully prior to use and must be accessible at all times.
The device may only be used in accordance with the intended use, any other
type of use is not permitted.
Individual warning notes must be observed in the corresponding chapters.
2.1 Infection hazard
Patients, users or third parties could be infected by contaminated medical
devices.
4Take suitable personal protective measures.
4Follow the instructions for use of the components.
4Before initial startup and after each use, reprocess the product and ac-
cessories appropriately.
4Carry out the reprocessing as described in the instructions for use. The pro-
cedure has been validated by the manufacturer.
4If you deviate from this validated procedure, make sure that the repro-
cessing procedure is effective.
4Reprocess the product and accessories appropriately before disposal.
2.2 Explosion hazard
Electrical sparks in the product can lead to explosion or fire.
4Do not use the product in explosion hazard areas.
2.3 Technical condition
If damaged, the device or components could injure patients, users and third
parties.
4Only operate devices or components if they show no signs of damage on the
outside.
4Check to make sure that the device is working properly and is in satisfactory
condition before each use.
4Have parts with sites of breakage or surface changes checked by the service
personnel.
4If the following defects occur, stop working and have the service personnel
carry out repair work:
▪ Malfunctions
▪ Damage
A damaged or leaking LCD could lead to injury or damage to the health of pa-
tients, users or third parties.
4Stop operation if the LCD is damaged.
4Avoid contact with fluid.
4In case of contact with the fluid, immediately rinse with water.
4Consult a physician if you notice any symptoms.
To ensure optimum function and to prevent property damage, please comply
with the following instructions:
4The device should be reprocessed and stored in a dry location, according to
instructions, if it is not to be used for an extended period of time.

Instructions for use DIAGNOdent display 2191
2 Safety | 2.4 Electromagnetic fields
7 / 32
2.4 Electromagnetic fields
Electromagnetic fields might interfere with the functions of implanted systems
(such as pacemakers).
4Do not use the device on a patient with implanted systems.
Information about electromagnetic compatibility
NOTE
Based on IEC 60601-1-2 (DIN EN 60601-1-2) concerning the electro-
magnetic compatibility of electrical medical devices, we must draw
your attention to the following points:
Medical electrical devices are subject to special precautions concerning the
electromagnetic compatibility and must be installed and operated in accord-
ance with the KaVo assembly instructions.
High-frequency communications devices may interfere with medical electrical
devices.
KaVo does not guarantee the compliance of accessories, cables, and other
components not supplied by KaVo with the EMC requirements of IEC
60601-1-2 (DIN EN 60601-1-2).
Also refer to:
10 Information about electromagnetic compatibility,Page29
2.5 Accessories and combination with other equipment
Use of non-authorised accessories or non-authorised modifications of the device
could lead to injury.
4Only use accessories that have been approved for combination with the
product by the manufacturer.
4Only use accessories that are equipped with standardised interfaces.
4Do not make any modifications to the device unless these have been ap-
proved by the manufacturer of the product.
A damaged or leaking battery could injure patients, users and third parties.
4Use leak-proof batteries only.
4Remove the battery during long downtimes.
4Properly dispose of used batteries.
4Do not use rechargeable batteries.
4Do not touch battery contacts and patient at the same time.
2.6 Qualification of personnel
Application of the product by users without the appropriate medical training
could injure patients, users or third parties.
4Make sure that the user has read and fully comprehends the instructions for
use.
4The device may be used only if the user has completed the appropriate
medical training.
4Observe national and regional regulations.
2.7 Service and repair
The following persons are authorised to repair and service the KaVo product:
▪ Service technicians of KaVo branches after the appropriate product training
▪ Service technicians of KaVo authorised dealers after the appropriate product
training
Observe all the following items during servicing work:

Instructions for use DIAGNOdent display 2191
2 Safety | 2.8 Disposal
8 / 32
4Have the service and testing tasks carried out according to the Medical
Device Operator Ordinance.
4KaVo recommends specifying in-house service intervals where the medical
device is brought to a professional shop for cleaning, servicing and a func-
tion check. Define the service interval depending on the frequency of use.
A safety check is not required.
Operators, equipment managers and users in Germany are obliged to operate
their equipment in compliance with the medical device law ("MPG"). The main-
tenance services encompass all the test tasks required in accordance with § 6
of the operator ordinance ("MPBetreiberV").
As a result of the use of NON-KaVo original spare parts during the repair, parts
may become detached and injure patients, users or third parties. This may res-
ult in aspiration, swallowing of parts and possibly even a risk of suffocation.
4Only use spare parts that comply with the specification for repair; original
KaVo spare parts comply with the specification.
NOTE
If a repair is done with NON-KaVo original spare parts, this may constitute a
product modification that leads to the loss of CE conformity. In the event of
damage, the responsibility is with the service company or the operator.
The introduction of a modified product in the market, in which the reasonable
suspicion exists to endanger the safety and health of patients or users, is pro-
hibited by Medical Device Law §4, Abs.1 No. 1 and therefore requires its own
conformity check.
2.8 Disposal
This product is subject to the EC directive governing waste electrical and elec-
tronic devices and must be submitted to special disposal in Europe.
4For further information, please contact KaVo or a specialised dental dealer.

Instructions for use DIAGNOdent display 2191
3 Description of the product | 3.1 DIAGNOdent display 2191
9 / 32
3 Description of the product
3.1 DIAGNOdent display 2191
①Infrared receiver ④Volume button
②ON/OFF button ⑤Key to display brightness
③Table holder for DIAGNOdent pen
2190

Instructions for use DIAGNOdent display 2191
3 Description of the product | 3.2 Intended use
10 / 32
①Bar display for MOMENT and PEAK ⑤PEAK display
②MOMENT display ⑥Brightness of the display (3 bright-
ness levels possible) temporary
display
③Battery charge display ⑦Volume of the signal beep (tem-
porary display)
④Reception quality
3.2 Intended use
General
The overarching guidelines and/or national laws, national regulations and the
rules of technology applicable to this product for putting into service and use of
the KaVo product for the indications for use are to be applied and complied
with.

Instructions for use DIAGNOdent display 2191
3 Description of the product | 3.3 Symbols on product, packaging and rating plate
11 / 32
This KaVo product is intended for use in dentistry only. Any other type of use is
not permitted.
The intended use also includes compliance with all notes provided in the in-
structions for use as well as compliance with prescribed inspections and main-
tenance.
Manipulations of the unit modifying it from its original condition are not per-
missible.
The use of this KaVo product is not permitted in areas subject to an explosion
hazard.
The functional safety and proper condition of the device must be checked be-
fore each use of the device.
The applicable national legal regulations must be observed during the use of the
device, in particular the following:
▪ Applicable regulations governing the connection and startup of medical
devices.
▪ Current occupational safety regulations.
▪ Current accident prevention regulations.
According to these regulations, the user is required:
▪ to only use equipment that is operating correctly
▪ to comply with the specified intended use
▪ to protect him or herself, the patient and third parties from hazards
▪ to prevent contamination from the product
Operators, equipment managers and users in Germany are obliged to operate
their equipment in compliance with the medical device law ("MPG"). The main-
tenance services encompass all the test tasks required in accordance with § 6
of the operator ordinance ("MPBetreiberV").
Product-specific
The DIAGNOdent display 2191 is only intended for dental treatment within the
context of dentistry. It is to be used in a dentist's office or dental clinic.
The DIAGNOdent display 2191 is a remote display of the
DIAGNOdent pen 2190 and provides patient information. To make a diagnosis
with the aid of the DIAGNOdent pen 2190, use the integrated display of the
DIAGNOdent pen 2190. Follow the instructions for use of the
DIAGNOdent pen 2190. Set up the DIAGNOdent display 2191 at a maximum
distance of 1.5m from the DIAGNOdent pen 2190.
We recommend that you do not place the DIAGNOdent display 2191 in the im-
mediate vicinity of fluorescent lights or powerful light sources since the data is
transmitted by infrared signals and it might cause interference or malfunction.
Only one DIAGNOdent pen 2190 with infrared data transmission may be used
in one room to display the data on the DIAGNOdent display 2191.
A safety check is not required.
3.3 Symbols on product, packaging and rating plate
The product, packaging or rating plates bear the following symbols.
The rating plate is located on the underside of the device.
Accompanying documents
Note: Please note accompanying documents

Instructions for use DIAGNOdent display 2191
3 Description of the product | 3.3 Symbols on product, packaging and rating plate
12 / 32
Follow instructions for use
Follow the electronic instructions for use
HIBC Code
Certification
CE- mark (European Community). A product bearing this mark meets
the requirements of the applicable EC directives.
VDE mark
MET mark
EAC conformity mark (Eurasian Conformity)
Medical device, labelling of medical devices
Product characteristics
Manufacturer
Manufacturing date
Device type
Material number
Serial number
UDI symbol
IP 4X IP 4X degree of protection against ingress of solid and liquid sub-
stances
+
Battery name
Do not dispose of with household waste
Transportation and storage conditions
(temperature range)
Transportation and storage conditions
(air pressure)

Instructions for use DIAGNOdent display 2191
3 Description of the product | 3.4 Technical Specifications
13 / 32
Transportation and storage conditions
(Humidity)
Protect from moisture (Keep dry)
Protect from impact
Permissible stacking load
3.4 Technical Specifications
Length approx. 17.5 cm
Width approx.10.5 cm
Altitude approx. 8.5 cm
Weight net 375 g
Voltage 6V
4 alkaline mignon cells LR6 (AA)
Power consumption <120mA
Carrier frequency of the infrared re-
ceiver
38kHz
Protection class covered IP4X
Permissible Ambient temperature +10 °C to +30 °C
Relative Humidity 30% RH to 75% RH
3.5 Transportation and storage conditions
CAUTION
Startup after refrigerated storage.
Malfunction.
4Prior to startup, strongly refrigerated products must be allowed to warm up
to a temperature of 20 °C to 25 °C (68 °F to 77 °F).
Temperature: -10°C to +50°C (14°F to +122°F)
Relative humidity: 5% RH to 85% RH absence of condensation
Air pressure: 700 hPa to 1060 hPa (10 psi to 15 psi)
Protect from moisture (Keep dry)

Instructions for use DIAGNOdent display 2191
3 Description of the product | 3.5 Transportation and storage conditions
14 / 32
3.5.1 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
receipt. The recipient and the representative of the shipping company must
sign this delivery receipt.
2. Leave the product and packaging in the condition in which you received it.
3. Do not use the product.
4. Report the damage to the shipping company.
5. Report the damage to KaVo.
6. Consult with KaVo first, before returning a damaged product.
7. Send the signed delivery receipt to KaVo.
If the product is damaged but there was no discernable damage to the pack-
aging on delivery, proceed as follows:
1. Report the damage to the shipping company immediately and no later than
7 days after delivery.
2. Report the damage to KaVo.
3. Leave the product and packaging in the condition in which you received it.
4. Do not use a damaged product.
NOTE
Failure on the part of the recipient to comply with any of the above-men-
tioned obligations will mean that the damage will be considered to have
arisen following delivery (in accordance with the General German Freight For-
warders' Terms and Conditions, Art. 28).
Outside Germany
NOTE
KaVo shall not be held liable for damage arising from transportation. The
shipment must be checked on arrival.
If the packaging is visibly damaged on delivery, please proceed as follows:
1. The recipient of the package must record the loss or damage on the delivery
receipt. The recipient and the representative of the shipping company must
sign this delivery receipt.
Without this evidence, the recipient will not be able to assert a claim for
damages against the shipping company.
2. Leave the product and packaging in the condition in which you received it.
3. Do not use the product.
If the product is damaged but there was no discernable damage to the pack-
aging on delivery, proceed as follows:
1. Report any damage to the shipping company immediately and no later than
7 days after delivery.
2. Leave the product and packaging in the condition in which you received it.
3. Do not use a damaged product.
NOTE
If the recipient fails to comply with any of the above-mentioned obligations,
the damage will be considered to have arisen following delivery (in accord-
ance with CMR law, Chapter 5, Art. 30).

Instructions for use DIAGNOdent display 2191
4 Startup | 4.1 Insert batteries
15 / 32
4 Startup
WARNING
Hazard from contaminated products.
Infection hazard to the dentist and patient.
4Prior to initial startup and after each use, reprocess the product and ac-
cessories.
WARNING
Dispose of the product in appropriate manner.
Infection hazard.
4Reprocess the product and accessories before disposal.
Also refer to:
7 Reprocessing steps in accordance with ISO 17664-1 / ISO 17664-2,Page25
CAUTION
Danger of injury from electric current.
Electric shock.
4Do not use power supply units.
4Only supply the product with the prescribed voltage.
4.1 Insert batteries
CAUTION
Risk of injury and material damage due to leaking batteries.
Risk of injury and material damage.
4Use leak-proof batteries only.
4Remove the battery during long downtimes.
4Properly dispose of used batteries.
4Do not use rechargeable batteries.
4Do not touch battery contacts and patient at the same time.
NOTE
Only use the type mignon LR6 alkaline cell.
Prerequisites
üOnly change batteries when the device is turned off.
4Open the battery cover ① and insert 4 conventional mignon alkaline LR6
cells matching the polarity. Close the battery cover.

Instructions for use DIAGNOdent display 2191
4 Startup | 4.1 Insert batteries
16 / 32
4Slide the DIAGNOdent display 2191 into the side of the table holder①.
DIAGNOdent display 2191 push forwards in the direction of the arrow②.

Instructions for use DIAGNOdent display 2191
4 Startup | 4.1 Insert batteries
17 / 32

Instructions for use DIAGNOdent display 2191
5 Operation | 5.1 Start up
18 / 32
5 Operation
CAUTION
Risks from electromagnetic fields.
Electromagnetic fields might interfere with the functions of implanted systems
(such as pacemakers).
4Do not use the device on a patient with implanted systems.
5.1 Start up
4Briefly press the ON-OFF button①.
ðThis is followed by a self-test of the DIAGNOdent display 2191. The
DIAGNOdent display 2191 is ready to receive.
ðIf data are not received within 0.4 sec., "- -" appears in the MOMENT and
PEAK displays. Otherwise the current values appear.
Prerequisites
üThe infrared transmitter in the DIAGNOdent pen 2190 must be switched
on.
4When switching on, hold the button for approx. 6 seconds to run the display
test (travelling vertical line).
ðAn antenna symbol appears in the LCD display of the
DIAGNOdent pen 2190.
Also refer to: Instructions for use DIAGNOdent pen 2190

Instructions for use DIAGNOdent display 2191
5 Operation | 5.2 Turn off
19 / 32
5.2 Turn off
4Press the ON-OFF button ① for 5 seconds.
ðIf no data is received within 90 seconds, the DIAGNOdent display 2191
switches off by itself.
ðAfter 30 minutes, the unit turns off even when data are being received.

Instructions for use DIAGNOdent display 2191
5 Operation | 5.2 Turn off
20 / 32