KaVo DIAGNOdent 2191 User manual

Instructions for use
DIAGNOdent display 2191

Distributed by:
KaVo Dental Technologies, LLC
11727 Fruehauf Drive
Charlotte, NC 28273 USA
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
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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 Product description ........................................................................................................... 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 Inserting the batteries.................................................................................................... 15
5 Operation........................................................................................................................... 18
5.1 Switching the device on.................................................................................................. 18
5.2 Switching the device 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 values.......................................................................... 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 preprocessing .................................................................................................... 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 preprocessing ............................................................................................... 26
7.4 Sterilization................................................................................................................... 26
8 Troubleshooting ................................................................................................................ 27
9 Disposal ............................................................................................................................. 28
10Information on 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
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1 User instructions
Dear User,
Congratulations on purchasing this KaVo quality product. By following the in-
structions 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 Technical Service
Please direct all questions regarding the product, service and maintenance to
the KaVo Technical Service:
Toll-free: 1-888-KAVOUSA (888-528-6872)
Email: [e-mail]
Please refer to the serial number of the product in all inquiries.
KaVo Repair Service
For repairs, please contact the KaVo Repair Service. For scheduling or if you
have any questions, please contact:
KaVo Dental Technologies, LLC
11727 Fruehauf Drive
Charlotte, NC 28273 USA
Toll-free Direct Customer Service: 1-888-KAVOUSA (888-528-6872)
Email: [e-mail]
www.kavo.com
Target group
The instructions for use are intended for medical professionals, in particular
dentists and office 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-sterilizable
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
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Hazard levels
The warning and safety notes in this document must be observed to prevent
personal injury and property 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.
NOTICE
In cases which – if not prevented – can lead to property damage.

Instructions for use DIAGNOdent display 2191
2 Safety | 2.1 Infection hazard
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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 a component of the product and must be read care-
fully prior to use and 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 can be infected by contaminated medical de-
vices.
4Take suitable personal protective measures.
4Follow the instructions for use of the components.
4Before initial startup and after each use, process the product and acces-
sories appropriately.
4Carry out the processing as described in the instructions for use. The proce-
dure has been validated by the manufacturer.
4If you deviate from this validated procedure, make sure that the processing
procedure is effective.
4Process 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 product in explosion hazard areas.
2.3 Technical condition
A damaged device or components can injure patients, users and third parties.
4Use the device and components only if there is no 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 Ser-
vice.
4If the following defects occur, stop working and have the service personnel
carry out repair work:
▪ Malfunctions
▪ Damage
A damaged or leaking LCD can cause bodily harm to patient, user or third par-
ties.
4If the LCD is damaged, discontinue using it.
4Avoid any contact with the fluid.
4Rinse with water after any contact with the fluid.
4Consult a physician if you experience any symptoms.
To ensure optimum function and to prevent property damage, please comply
with the following instructions:
4The product should be processed 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
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2.4 Electromagnetic fields
Electromagnetic fields might interfere with the functions of implanted systems
(such as cardiac pacemakers).
4Do not use the device in patients who have implanted systems.
Information on 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 accor-
dance 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 on electromagnetic compatibility,Page29
2.5 Accessories and combination with other equipment
Use of un-authorized accessories on the device or un-authorized modifications
to the device can 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 standardized interfaces.
4Do not make any modifications to the device unless these have been ap-
proved by the manufacturer of the product.
A damaged or leaky battery can injure patients, users and third parties.
4Use leak-proof batteries only.
4Remove the battery during extended downtimes.
4Properly dispose of spent 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 lacking appropriate medical training can in-
jure the patient, the user or third parties.
4Make sure that the user has read and comprehends the instructions for use.
4Only employ the device if the user has the appropriate medical training.
4Comply with national and regional regulations.
2.7 Service and repair
The following persons are authorized to repair and service the KaVo product:
▪ Service technicians of KaVo branches after the appropriate product training
▪ Service technicians of KaVo authorized dealers after the appropriate product
training
Comply with the following items during all servicing work:
4Have the service and testing tasks carried out in accordance with the Medi-
cal Device Operation Ordinance.

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2 Safety | 2.8 Disposal
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4Have the medical device evaluated by a professional shop with regard to its
cleaning, servicing and functional needs according to an in-house service in-
terval. Define the service interval depending on the frequency of use.
No safety check is required.
Operators, equipment managers and users in Germany are obliged to operate
their equipment in accordance with the regulations of the German Medical De-
vices Law. The 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
such as covers may become undone and injure the patient, user or third par-
ties. This may result 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 into the market of a modified product, where there is reason-
able suspicion that the safety and health of patients or users may be jeopar-
dized, is prohibited by the German medical device law §4, section 1 no. 1 and
requires a separate 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 more information, please contact KaVo or a specialized dental dealer.

Instructions for use DIAGNOdent display 2191
3 Product description | 3.1 DIAGNOdent display 2191
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3 Product description
3.1 DIAGNOdent display 2191
①Infrared receiver ④Volume button
②ON/OFF button ⑤Display brightness key
③Table holder for DIAGNOdent pen
2190

Instructions for use DIAGNOdent display 2191
3 Product description | 3.2 Intended use
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①Bar display for MOMENT and PEAK ⑤PEAK display
②MOMENT display ⑥Display brightness (3 brightness
levels possible) temporary display
③Battery charge display ⑦Volume of the beep (temporary
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 commissioning and use of the
KaVo product for the indications for use are to be applied and complied with.
This KaVo product is intended for use in dental medicine only. Any other type of
use is not permitted.

Instructions for use DIAGNOdent display 2191
3 Product description | 3.3 Symbols on product, packaging and rating plate
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The proper use also includes compliance with all notes provided in the instruc-
tions for use as well as compliance with specified inspections and maintenance.
Manipulations of the unit modifying it from its original condition are not permis-
sible.
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.
CAUTION
US Federal law restricts this device to sale by or on the order of a
healthcare professional / dentist.
For dental use only.
The applicable national legal provisions must be heeded during the use of the
device, in particular the following:
▪ Applicable regulations governing the connection and startup of medical de-
vices.
▪ Current occupational safety regulations.
▪ Current accident prevention regulations.
In accordance with these regulations, the user is required to:
▪ only use equipment that is operating properly
▪ adhere to the specified intended use
▪ protect himself or herself, the patient and third parties from danger
▪ avoid contamination from the product
Operators, equipment managers and users in Germany are obliged to operate
their equipment in accordance with the regulations of the German Medical De-
vices Law. The services encompass all the test tasks required in accordance
with § 6 of the operator ordinance ("MPBetreiberV").
Product-specific
The DIAGNOdent display 2191 is designed for dental treatments in the field of
dentistry only. It is to be used in a dentist's office or dental clinic.
The DIAGNOdent display 2191 is a remote display for the
DIAGNOdent pen 2190 and serves purposes of patient information. To make a
diagnosis with 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 distance of
max 1.5m from the DIAGNOdent pen 2190.
We recommend that you do not place the DIAGNOdent display 2191 right next
to fluorescent lights or powerful light sources since the data is transmitted by
infrared signals and interference may be possible. Only one
DIAGNOdent pen 2190 with activated infrared data transmission may be used
in any room to display the data on the DIAGNOdent display 2191.
No safety check is required.
3.3 Symbols on product, packaging and rating plate
The product, packaging or rating plate bear the following symbols.
The rating plate of the device is located on the underside of the device.

Instructions for use DIAGNOdent display 2191
3 Product description | 3.3 Symbols on product, packaging and rating plate
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Accompanying documents
Attention: Please consult the accompanying documents
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 directive.
VDE mark
MET mark
EAC conformity mark (Eurasian Conformity)
Medical device, labeling of medical devices
Product characteristics
Manufacturer
Manufacturing date
Device type
Catalog number
Serial number
UDI symbol
IP X4 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)

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3 Product description | 3.4 Technical Specifications
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Transportation and storage conditions
(air pressure)
Transportation and storage conditions
(humidity)
Protect from moisture
Protect from impact
Permissible stacking load
3.4 Technical Specifications
Length approx. 17.5cm
Width approx. 10.5cm
Height approx. 8.5cm
Weight net 375g
Voltage 6V
4 alkaline mignon cells LR6 (AA)
Power consumption <120mA
Carrier frequency the infrared receiver 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
NOTICE
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

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3 Product description | 3.5 Transportation and storage conditions
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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 packag-
ing 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 only after the time of 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
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 packag-
ing 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 only after the time of delivery
(in accordance with CMR law, Chapter 5, Art. 30).

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4 Startup | 4.1 Inserting the batteries
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4 Startup
WARNING
Hazard from contaminated products.
Infection hazard for dentist and patient.
4Prior to initial startup and after each use, process the product and acces-
sories.
WARNING
Dispose of the product in the appropriate manner.
Infection hazard.
4Process 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 voltage.
Electric shock.
4Do not use power supplies.
4Supply the specified voltage to the device only.
4.1 Inserting the batteries
CAUTION
Risk of injury and property damage due to leaky battery.
Risk of injury and property damage.
4Use leak-proof batteries only.
4Remove the battery during extended downtimes.
4Properly dispose of spent batteries.
4Do not use rechargeable batteries.
4Do not touch battery contacts and patient at the same time.
NOTE
Only use mignon LR6 type alkaline cell.
Requirement
üOnly change batteries when the device is turned off.
4Open the battery cover ① and insert 4 commercially available mignon alka-
line LR6 cells matching the polarity. Close the battery cover again.

Instructions for use DIAGNOdent display 2191
4 Startup | 4.1 Inserting the batteries
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4Insert the DIAGNOdent display 2191 from the side in the table holder①.
Push DIAGNOdent display 2191 forwards in the direction of the arrow②.

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4 Startup | 4.1 Inserting the batteries
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Instructions for use DIAGNOdent display 2191
5 Operation | 5.1 Switching the device on
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5 Operation
CAUTION
Risks from electromagnetic fields.
Electromagnetic fields might interfere with the functions of implanted systems
(such as cardiac pacemakers).
4Do not use the device in patients who have implanted systems.
5.1 Switching the device on
4Briefly press the ON-OFF button ①.
ðThe DIAGNOdent display 2191 performs a self-test. After which the
DIAGNOdent display 2191 is ready for reception.
ðIf no data is received within 0.4 sec., "- -" is shown in the MOMENT and
PEAK displays. Otherwise the current values are shown.
Requirement
üThe infrared transmitter in the DIAGNOdent pen 2190 must be switched
on.
4When you switch the device on, keep the button pressed for approx. 6 sec-
onds to run a display test (migrating vertical line).
ðAn antenna symbol is shown in the LCD display of the
DIAGNOdent pen 2190.
Also refer to: Instructions for use DIAGNOdent pen 2190

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5 Operation | 5.2 Switching the device off
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5.2 Switching the device off
4Press the ON-OFF button ① for 5 seconds.
ðIf no data is received within 90 seconds, the DIAGNOdent display 2191
switches off automatically.
ðAfter 30 minutes, the unit is switched off forcibly even if data are being re-
ceived.

Instructions for use DIAGNOdent display 2191
5 Operation | 5.2 Switching the device off
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