KaVo Dig eXam 3520, 3530 Instructions for use

Instructions for useKaVo Dig eXam 3520, 3530

Always be on the safe side.

Sales:KaVo Dental GmbHBismarckring 39D-88400 BiberachTel. +49 7351 56-0Fax +49 7351 56-1488

Manufacturer:Kaltenbach & Voigt GmbHBismarckring 39D-88400 Biberachwww.kavo.com

Instructions for use KaVo Dig eXam 3520, 3530Contents

Contents

Contents ...........................................................................................................................................................1 1 User notes .....................................................................................................................................................3

1.1 Intended users .........................................................................................................................................31.2 User guidelines ........................................................................................................................................4

1.2.1 Standard documentation ..................................................................................................................41.2.2 Abbreviations ...................................................................................................................................41.2.3 Symbols used ...................................................................................................................................51.2.4 Symbols on nameplates ...................................................................................................................5

1.3 Service .....................................................................................................................................................61.4 Implied warranty .......................................................................................................................................71.5 Limitation of implied warranty ..................................................................................................................81.6 Transportation and storage ......................................................................................................................9

1.6.1 Transportation damage ....................................................................................................................91.6.2 Information on the packaging: Storage and transport ......................................................................9

2 Safety ..........................................................................................................................................................11

2.1 Explanation of safety symbols ...............................................................................................................112.1.1 Hazard warning symbol ..................................................................................................................112.1.2 Explanation of different levels of hazard ........................................................................................112.1.3 Structure .........................................................................................................................................11

2.2 Intended purpose ...................................................................................................................................122.2.1 General ..........................................................................................................................................122.2.2 Product-specific ..............................................................................................................................12

2.3 Safety symbols .......................................................................................................................................142.4 Prerequisite for proper technical operation ............................................................................................16

2.4.1 Data backup ...................................................................................................................................162.4.2 Sensor handling .............................................................................................................................172.4.3 Standards for IT-components .........................................................................................................182.4.4 Standard conformity .......................................................................................................................18

3 Product description ......................................................................................................................................20

3.1 Entire system .........................................................................................................................................203.2 Where to affix the nameplates, power rating plates and caution labels .................................................21

3.2.1 Labeling ..........................................................................................................................................213.2.2 Symbols on identification labels .....................................................................................................23

3.3 Sensors ..................................................................................................................................................243.3.1 Installation sizes .............................................................................................................................243.3.2 KaVo Trigger ..................................................................................................................................253.3.3 Data connection via USB 2.0 .........................................................................................................253.3.4 Portability of KaVo Dig eXam .........................................................................................................263.3.5 Holder system for sensor ...............................................................................................................26

3.4 Integration in KaVo In eXam ..................................................................................................................273.4.1 Attaching sensors to KaVo In eXam ..............................................................................................273.4.2 Internal USB connection in the scissor arm ...................................................................................28

3.5 Sensor holder .........................................................................................................................................293.5.1 Active Sensor holder ......................................................................................................................29

3.6 Status icon and sensor status on the PC ...............................................................................................31

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Instructions for use KaVo Dig eXam 3520, 3530Contents

3.7 Technical Data .......................................................................................................................................333.7.1 KaVo Dig eXam Sensors and Interface .........................................................................................333.7.2 IT component requirements ...........................................................................................................333.7.3 Ambient conditions for KaVo Dig eXam sensors and interface [compliant with IEC601-1] ............343.7.4 Equipment classification .................................................................................................................343.7.5 Conformity with standards ..............................................................................................................343.7.6 Electrical connection ......................................................................................................................353.7.7 Dimensions, mass (original packaging) .........................................................................................353.7.8 Exposure times ..............................................................................................................................353.7.9 Information on electromagnetic compatibility .................................................................................36

3.8 Dig eXam inspection service (only available in Germany) .....................................................................39 4 Operation .....................................................................................................................................................40

4.1 Configuration of the Dig eXam driver software ......................................................................................404.1.1 Selection Information .....................................................................................................................404.1.2 Selection configuration ...................................................................................................................414.1.3 Selection parameters .....................................................................................................................43

4.2 Taking a digital X-ray .............................................................................................................................444.2.1 Overview ........................................................................................................................................444.2.2 Activate programme and select patient ..........................................................................................444.2.3 Prepare and position sensor ..........................................................................................................454.2.4 X-ray ...............................................................................................................................................474.2.5 Conclude X-ray procedure .............................................................................................................494.2.6 Create a diagnosis based on the radiograph .................................................................................49

5 Maintenance/safety inspections ..................................................................................................................50

5.1 Checks ...................................................................................................................................................50 6 Preparation methods DIN EN ISO 17664 ....................................................................................................51

6.1 Cleaning and disinfecting .......................................................................................................................516.1.1 Cleaning .........................................................................................................................................516.1.2 Disinfection .....................................................................................................................................51

7 Accessories and compatibility .....................................................................................................................53

7.1 eXam Family ..........................................................................................................................................537.2 Compatibility ..........................................................................................................................................57

7.2.1 Non-KaVo X-ray machines .............................................................................................................577.2.2 IT components ...............................................................................................................................57

8 Troubleshooting ...........................................................................................................................................58

8.1 Symptoms, causes and solution ............................................................................................................59

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Instructions for use KaVo Dig eXam 3520, 3530

1 User notes | 1.1 Intended users

1 User notes

1.1 Intended users

This document is intended for use by dentists and other practice or clinic employeeswho are conversant with the taking, processing and archiving of computer-basedintraoral X-rays on the Microsoft® Windows operating system .Prior to using the equipment, it assumed that users have been instructed in the useof KaVo Dig eXam-Sensors in accordance with the stipulations of the country inwhich they are practising, on the safe and proper use of X-ray radiation for the takingof intraoral dental X-rays.

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1 User notes | 1.2 User guidelines

1.2 User guidelines

RequirementRead these instructions before the initial startup to prevent misuse and damage.

This document has been translated from the German original.

NoteMicrosoft and Windows are registered trademarks of Microsoft Corporation and itsregistered subsidiaries.VixWin PRO is a registered trademark of Gendex Dental Systems.XCP-DS is a registered trademark of DENTSPLY RINN.KaVo Dig eXam is a protected trademark of KaVo.The utilisation of company logos or trademarks not named here does not indicatethat they are subject to unrestricted use. Every company logo or trademark men‐tioned here is the sole property of the company mentioned. Brands, names andprices are given for information purposes only.

1.2.1 Standard documentation

The product-related documentation consists of the following components. You canorder more of these from KaVo, if necessary:▪ Customer documents

– User instructions– Assembly instructions

▪ User instructions Software VixWin PRO.

1.2.2 Abbreviations

Abbrevia‐tion

Meaning

ALARA "As low as reasonably achievable": The guiding principle behind radiation protection during thetaking of X-rays, meaning that radiation doses for both workers and the public are typically keptlower than their regulatory limits.

EMC Electromagnetic compatibilityUI User instructionsHub A central point: a distribution device that makes available a number of USB interfaces.IEC International Electrotechnical CommissionAI Assembly instructionsSQL "Structured Query Language": Standardised computer language for querying relational databasesSFC Safety checksSW SoftwareSTI Service Technician's instructionsUSB Universal Serial Bus. Standardised means of connecting peripherals to personal computers.

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1 User notes | 1.2 User guidelines

1.2.3 Symbols used

See the section Safety/Warning Symbol

Important information for users and technicians

Action request

1.2.4 Symbols on nameplates

Type BF application part [5333;IEC 417]

Consult user instructions

CE (Communauté Européenne) mark. Products bearing this mark conformto the requirements of the pertinent EC directives (applicable Europeanstandards).CSA label

SN: Serial numberREF: Material number (for sensor size IMat. no. 1.003.4498, for sensor size

IIMat. no. 1.003.4499)Type: device type (for sensor size I 3520, for sensor size II 3530)

For information about proper disposal, see intended purpose

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1 User notes | 1.3 Service

1.3 Service

Service hotline:+ 49 (0) 7351 [email protected] indicate the version number of the program.Additional information can be obtained at: www.kavo.com

For North America

KaVo DentalKaVo Technologies / Gendex Imaging019 West Oakton StreetDes Plaines, IL 60018-1884USA+1 (847) 640-48 00

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1 User notes | 1.4 Implied warranty

1.4 Implied warranty

The KaVo end-user customer guarantee for the product named in the completioncertificate guarantees that the product functions correctly and that there are no faultsin the material or workmanship for a duration of 12 months following the purchasedate, according to the following conditions:Following a reasonable complaint relating to defects or short delivery, KaVo willprovide a replacement or perform repairs. KaVo reserves the right to perform re‐pairs.Claims of any other nature, damages in particular, are excluded. In case of defaultand gross negligence or intent, the latter only applies if there are no compelling legalprovisions opposing it.KaVo shall not be liable for defects and their consequences, which occur as a resultof normal normal wear and tear, or of improper cleaning and maintenance, non-observance of the operating, maintenance or connection regulations; calcination orcorrosion; a contaminated air or water supply; or chemical or electrical effects, whichare non-standard or not permitted according to company regulations.As a general rule, this guarantee does not apply to lamps, glassware, rubber partsor the colour durability of synthetic materials.KaVo shall not be liable for defects or their consequences if they are likely to be adirect result of actions or modifications by a customer or third party.Any claims arising from this guarantee can only be lodged if the completion certifi‐cate (carbon copy) has been sent in to KaVo and the operator/user is able to producethe original.

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1 User notes | 1.5 Limitation of implied warranty

1.5 Limitation of implied warranty

KaVo shall assume responsibility for the safety, reliability and performance of allKaVo system components provided that:▪ Assembly, upgrades, new settings, modifications or repairs are all carried out

by Service Technicians, who have been trained by KaVo, or by KaVo authoriseddealer personnel

▪ The IT components provided by the operator correspond to the technical hard‐ware and software requirements included in these user instructions.

▪ The system has been installed and operated in accordance with the User in‐structions and Assembly instructions.

▪ All servicing is performed in full compliance with DIN VDE-075-1.▪ In Germany, the location in whichKaVo Dig eXam is installed, must comply with

the regulationsDIN VDE 0100-710: 2002-11 and VDE 0100-560:1995 in its de‐sign. In other countries, the corresponding national regulations must be respec‐ted.

▪ The VixWin PRO software has been installed in accordance with the VixWin Prouser instructions

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1 User notes | 1.6 Transportation and storage

1.6 Transportation and storage

1.6.1 Transportation damage

Outside of Germany

NoteKaVo is not liable for damage arising from transportation.Immediately inspect the delivery after receipt!

If external damage to the packaging is visible upon delivery, follow the procedurebelow:1. The recipient must record the loss or damage in the notice of delivery. The re‐

cipient and employee of the transportation firm must sign the notice of delivery.The recipient can only assert damages against the transportation company ba‐sed on these records.

2. Leave the product and packaging unchanged.3. Do not use the product.

If the product is damaged and there is no discernable damage to the packagingupon delivery, proceed as follows:1. Report the damage immediately or at least 7 days after the delivery to the deli‐

very company .2. Leave the product and packaging unchanged.3. Do not use a damaged product.

NoteIf the recipient does not follow one of the above instructions, the damage will beheld to have occurred after the delivery (according to . CMR law , section 5, Art.30).

1.6.2 Information on the packaging: Storage and transport

NoteKeep the packaging for returning the product for service or repairs .

The symbols printed on the outside are for transportation and storage, and have thefollowing meaning:

Transport upright with the arrows pointing upwards

Fragile - protect against knocks

Keep dry

Maximum permitted stacking load

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1 User notes | 1.6 Transportation and storage

Temperature range

Humidity

Air pressure

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2 Safety | 2.1 Explanation of safety symbols

2 Safety

2.1 Explanation of safety symbols

2.1.1 Hazard warning symbol

Warning symbol

2.1.2 Explanation of different levels of hazard

Safety instructions with three hazard levels are used in this document for avoidingpersonal and property damage.

CAUTION

CAUTIONindicates a hazardous situation that can lead to property damage or minor to mo‐derate injury.

WARNING

WARNINGindicates a hazardous situation that can lead to serious injury or death.

DANGER

DANGERindicates a maximum hazardous situation that can directly cause serious injury ordeath.

2.1.3 Structure

DANGER

The introduction describes the type and source of the hazard.This section describes the potential consequences of non-observance.▶ The optional step contains necessary measures for avoiding hazards.

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2 Safety | 2.2 Intended purpose

2.2 Intended purpose

2.2.1 General

This KaVo product is intended only for use in the field of dentistry. It is impermissibleto use the product for a purpose for which it was not intended."Proper use" includes following all the instructions for use and ensuring that all in‐spections and service tasks are performed.

Apply and meet the overarching guidelines and/or national laws, national regulati‐ons and the rules of technology for medical devices applicable for startup and useof the KaVo product for the intended purpose.

The user must ensure that that the device works properly and is in a satisfactorycondition before each use.

During use, national legal regulations must be observed, in particular:▪ the applicable health and safety regulations.▪ the applicable accident prevention regulations.

The user must observe the following:▪ - only use properly operating equipment.▪ protect himself or herself and third parties from danger.▪ avoid contamination from the product.

The safety checks (SFC) must be performed on an annual basis.

NoteThe product must be cleaned and serviced according to instructions if it is not tobe used for a long period.

Observe the corresponding country-specific regulations when finally shutting downa KaVo product. Please direct all questions regarding the proper disposal of KaVoproducts to the nearest KaVo branch.

2.2.2 Product-specific

Dig eXamtogether with VixWin PRO is intended for processing dental, intraoral X-rays.The radiographs are displayed and archived using the software VixWin PRO.Prior to using the equipment, users of the KaVo Dig eXam-Sensors must have un‐dergone full instruction, in accordance with the stipulations of the country in whichthey are practising, on the safe and proper use of X-ray radiation for the taking ofintraoral dental X-rays.

KaVo Dig eXam has electronic components in the Trigger and Sensor that are tobe disposed of in accordance with the relevant country specific regulations.

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2 Safety | 2.2 Intended purpose

Disposal of electronics

NoteAccording to the EC Directive 2002/96 concerning electrical and electronic useddevices, this product is subject to the cited directive and must be disposed accor‐dingly within Europe.Before disassembling and disposing of the product, it must be completely proces‐sed (disinfected, sterilised) according to the section "Preparation methods".Additional information can be obtained from KaVo (www.kavo.com) or your dentalsupplier.

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2 Safety | 2.3 Safety symbols

2.3 Safety symbols

CAUTION

Ionising radiationOverexposure to X-ray radiation.▶ The handler can and must take measures, in accordance with country-specific

legal stipulations, to minimise their personal dose of radiation!

CAUTION

Risk of injury by using unsuitable electrical devices.Increased risks within patient surroundings; e.g. sensing electrical current or re‐ceiving electric shock through contact with parts▶ Adhere to the requirements described within these user instructions▶ Only use IT components that are fully compliant with the requirements descri‐

bed within these user instructions.▶ If any of the system components are damaged, stop use immediately.▶ Only use standard-compliant devices.

CAUTION

Injury caused by damaged sensorsDamaged sensors may cause personal injury.▶ If sensors are damaged, stop using them.▶ If the sensor wire is damaged, stop using it.

CAUTION

Ignition of ignitable mixtures due to electrical equipment in operationDeflagration▶ KaVo Dig eXam must not be operated when using ignitable mixtures.

CAUTION

Malfunctions from electromagnetic fields.The product meets the applicable requirements regarding electromagnetic fields.Given the complex interactions between equipment and cell phones, the productmay be influenced by a cell phone that is in use.▶ Do not use cell phones in medical offices, hospitals, or laboratories.▶ Turn off electronic devices such as computer storage media, hearing aids, etc.

during operation .

CAUTION

Risks from electromagnetic fields.The functions of implanted systems (such as pacemakers) can be influenced byelectromagnetic fields.▶ Ask patients before treatment.

CAUTION

Loss of data when taking x-raysWhen the transmission of data from the KaVo Dig eXam sensor to the computerdoes not meet the USB 2.0 standard, data may be lost when taking x-rays due tothe limited bandwidth of earlier USB versions.▶ Each USB connection between the computer and sensor must completely meet

the USB 2.0 standard.▶ Each port (computer or hub) to which the sensors are connected must offer the

full output of 500 mA specified fur USB.▶ The operating system for the computer must support USB 2.0 in high-speed

mode. The most recent service pack by Microsoft must be installed.▶ The protective conductor connections described in these instructions must be

installed.

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2 Safety | 2.3 Safety symbols

CAUTION

Monitor image interference preventing accurate diagnosisThe quality of the X-ray image displayed on screen is dependent both on the prac‐tice or clinic's ambient conditions as well as the monitor settings.▶ If you suspect interference on the image display, use test images to check

whether the problem lies with the monitor.▶ Clean the screen on a regular basis.▶ Make sure that you use correct screen settings only.

NoteWhen positioning the screen, keep it out of direct sunlight and prevent light reflec‐ting off it to enable the medical data to be read properly.

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2 Safety | 2.4 Prerequisite for proper technical operation

2.4 Prerequisite for proper technical operation

Responsibility is assumed for the safety, reliability and performance of the compo‐nent supplied by KaVo when:▪ Installation, expansions, adjustments, changes or repairs is done by technicians

trained by KaVo or third parties authorised by KaVo for the Dig eXam, or by thepersonnel of authorised distributors.

▪ The unit is operated according to the instructions for use and installation.▪ The IT components supplied by the operator meet the technical requirements in

these instruction for use for hardware and software, and they are installed andset up according to the descriptions of these components.

▪ KaVo Dig eXam is an electronic medical device, and is subject to the specialprecautions necessary for EMC. KaVo Dig eXam may only be operated when ithas been installed according to the EMC instructions in the instructions for useand installation.

▪ When setting up the unit, follow all the requirements of VDE 0751-1, "Repeatedtests and test before startup of electronic medical devices and systems - generalguidelines".

▪ In Germany ,the room in which the Dig eXam is installed must be designed ac‐cording to the specifications DIN VDE 0100-710:2002-11 ad VDE0100-560:1995. In other countries, follow the corresponding national specifica‐tions.

NoteThe installation and fitting of IT components for Dig eXam are the responsibility ofthe practice or clinic.

CAUTION

Unauthorised accessoriesOnly original replacement parts and accessories should be used, to ensure thatthere is no increase in the emissions and/or a reduction in the stability in terms ofthe electromagnetic compatibility.▶ Only use authorised or recommended spare parts and accessories.

See also: 3.7 Technical Data, Page 33

Observe the corresponding country-specific regulations when finally shutting downa KaVo product. Please direct all questions regarding the proper disposal of KaVoproducts to the nearest KaVo branch.

See also: Technical data in user instructions.

2.4.1 Data backup

It is the user's responsibility alone to back up data.

KaVo recommends daily back-up.

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CAUTION

Data lossEstablish a data backup strategy.▶ VixWin PROuses the file system supplied with the Microsoft operating system

for saving image data. Correspondingly, this data must also be included withinthe backup strategy of your practice or clinic.

NoteThe image data produced using KaVo Dig eXam replaces the conventional intraoralradiographs taken on X-ray film and, as such, is subject to the same country-spe‐cific requirements governing this; such as the mandatory length of time for storingX-rays etc.These country-specific stipulations and requirements may also include the recor‐ding of dosage levels and information about the patient's indication.

The user should regularly make back-up copies If a hard disk in the PC fails, thisprotects from data loss and increases the safety of the system data. Such a copy isalso termed a backup. It should not be confused with the export of data in which thedata remain in the PC.Store backup copies in a safe place.

There are various backup options. You can choose between:▪ A full backup, which always backs up every single piece of data on the hard drive

that needs backing up.▪ An incremental backup, which only saves data that has been modified since the

last backup.

A full backup is a lengthy procedure and cannot be performed on a daily basis.Therefore, practices nowadays usually decide to implement a hybrid of the twobackup options (full and incremental). whereby, at one point in time, the entirequantity of stored data is backed up and, on later occasions, backups are run atregular intervals for modified data only.Please also note that a hard drive error may occur whilst a backup is being written.For this reason, you should never overwrite the most recent backup copy.

NoteThe computer expert or system administrator at your practice will have the mostup-to-date technical information as regards keeping and running backup copies.

2.4.2 Sensor handling

Precautionary instructions for handling the sensors

Never:▪ Sterilise the sensors or subject them to high-pressure sterilisation (autoclave).▪ Drop the sensors.▪ Twist or tread on the sensor wires.▪ Let patients bite on the sensor or its wire.▪ Remove the sensors when in use or while the X-ray is being taken.▪ Pull or bend the wire..▪ Immerse the KaVo trigger in the cleaning bath.

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Electrostatic discharge

▪ When the sensors are not in use, it is recommended that they be stored in thestorage containers provided.

▪ Never touch the USB connection contact points!

2.4.3 Standards for IT-components

The IT components used in conjunction with Dig eXam, in particular USB-connec‐tion between Dig eXam and the PC must correspond with the details given in theseUser instructions.

See also: 2.4.4 Standard conformity, Page 18

See also: 3.3.3 Data connection via USB 2.0, Page 25

2.4.4 Standard conformity

The KaVo Dig eXam Sensors and the KaVo Dig eXam Interface comply with thefollowing standards▪ IEC 60601-1:1988 +A1:1991 + A2:1995 [For the USA UL 60601-1:2003. For

Canada CAN/CSA 22.2 N0.: 601-1]▪ IEC 60601-1-2:2001

The KaVo Dig eXamdriver software conforms to standards:▪ IEC 60601-1-4: 1996 + A1: 1999

NoteThe delivered Vix Win Pro software also meets this standard.

KaVo Dig eXam and the IT components together make up a medical, electrical sys‐tem.The standards applicable to these IT components depend on their specific locationwithin the practice or clinic. In general, these IT components must comply with IEC60950-1:2001.The system that is formed by these IT components andKaVo Dig eXam when in‐stalled in accordance with the assembly instructions for KaVo Dig eXam and meetsthe requirements stipulated in this section, conforms to standard- IEC 60601-1-1:2000

Rooms used for medical purposes

The room where KaVo Dig eXam Sensors are operated, must be designed in ac‐cordance with regulationDIN VDE 0100-710:2002-11. In other countries, the corre‐sponding national regulations must be respected.

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patient environment

When the above-mentioned IT components are installed in the patient environment,the requirements of basic specialist standard IEC 60601-1:1988 +A1:1991 +A2:1995defines the surroundings of the patient in accordance with IEC 60601-1-1:2000: „ ...any volume whereby, intentionally or unintentionally, a connection may be createdbetween the PATIENT and parts of the SYSTEM or other persons who may comeinto contact with parts of the SYSTEM. ... “

Medical system

The requirements of the applicable standards have been met if:▪ The IT-components on the Dig eXam via USB are installed in the same room

and▪ One of the following applies:

– The Dig eXam Sensor together with the Dig eXam Interface is connected(integrated solution in In eXam or in connection with the active sensor holderof Dig eXam). The IT device can be run in accordance with IEC 60950-1 ifarranged outside of the patient surroundings.

– The IT components are located within the patient environment: The deviceon which the Dig eXam is connected directly, fulfills the standard IEC60601-1.

– The IT components are located outside of the patient environment: The de‐vice is on which the Dig eXamis directly connected, complies with thestandard IEC 60950-1 and has a second permanently connected equipo‐tential bonding that complies with IEC 60601-1-1.

Monitors

NoteThe dental radiographs created byKaVo Dig eXam are examined and diagnosedusing the dental practice's own image representation device (monitor). There arecountry-specific regulations in force governing (regular) check-ups of the greyscaledisplay for these image representation devices.In Germany, at least one monitor at the dental practice must be tested for constancyon a regular basis in accordance with DIN-V 6868-57:2001.

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3 Product description | 3.1 Entire system

3 Product description

3.1 Entire system

The entire KaVo Dig eXam consists of:- the ① Dig eXam Sensors (comprising detector and trigger, the KaVo Dig eXam-Interface (optional), the ② Dig eXam-Driver-Software- the ③ VixWin PRO-Software- IT-components- accessoriesKaVo Dig eXam and the VixWin PRO-Software together form a complete systemwhich can easily be used with non-KaVo X-ray machines.Used in conjunction with KaVo In eXam and the Dig eXam interface, you have afully integrated X-ray system with extra functions.

Dig eXam has two additional software programs for customers in Germany:1. A tool for supporting the required acceptance and constancy test in Germany.2. A program for listing the existing images (x-ray folder)

HUB

HUB

HUB

HUB

< 5m

< 5m

1

1

2

3

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3 Product description | 3.2 Where to affix the nameplates, power rating plates and caution labels

3.2 Where to affix the nameplates, power rating plates and cautionlabels

3.2.1 Labeling

K a V o Dig e X am 1

A

C

B

5

3 2

4

X. XX X. XXX X XXXXX X

Dig eXam Sensor Size 1 Kaltenbach & V oigt Gmb H Bismarckring 39 D-88400 Biberach / Riss

!

3520 T ype : Ref : 1.003.4498 SN :

Manufactored : Month, Y ea r USB 2.0 max. 500 mA

6

① Product name ⑥ Rating plate overview (on packaging)② Consult user instructions (A) Dot to mark position. This is entered

automatically on the radiographs byKaVo Dig eXam.

③ Type BF application part (B) Sensor label (sensor I or sensor II)④ KaVo Dig eXam sensor rating plate (C) USB symbol on connector⑤ Label for KaVo Trigger/USB lead

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Hardware driver for Vix-Win Mat. no. 1.002.8220

① Program version ③ Unambiguous ID② ID and language edition

Installations CD Vix Win Pro. Mat. no. 1.002.4813

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3.2.2 Symbols on identification labels

Type BF application part [5333;IEC 417]

Consult user instructions

CE (Communauté Européenne) mark. Products bearing this mark conformto the requirements of the pertinent EC directives (applicable Europeanstandards).CSA label

SN: Serial numberREF: Material number (for sensor size IMat. no. 1.003.4498, for sensor size

IIMat. no. 1.003.4499)Type: device type (for sensor size I 3520, for sensor size II 3530)

For information about proper disposal, see intended purpose

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3 Product description | 3.3 Sensors

3.3 Sensors

3.3.1 Installation sizes

Sensor I (left) and sensor II (right).

The receiver side is marked with a dot that is also shown on the digital X-ray.

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3.3.2 KaVo Trigger

KaVo Trigger

The KaVo trigger connects the X-ray image detector to the computer system via aUSB 2.0 data path. This connection takes place in the X-ray deviceKaVo In eXamsimply by inserting the interface in the X-ray head and in theKaVo Dig eXamfitted in the machine.When using the Dig eXam sensors with other X-ray machines it is possible to con‐nect the KaVo Trigger to the so-called "active sensor holder" or alternatively toconnect it directly to the computer using the accessory cable supplied. In this casea Dig eXAM sensor of one size can be exchanged with a sensor of another size bychanging the trigger.

NoteThe accessory line is "Pull/Push“-Connection. It must not be twisted when pulledout and plugged in.

when changing the Dig eXam Sensor from machine to machine or for another sensorsize, the detector can be laid down in the sensor holder fitted on the KaVo Trigger.This sensor holder can be removed for cleaning the KaVo Trigger..

When the sensor holder is opened and the detector is removed, a button is acces‐sible.This button directly activates the system to take x-rays when the Dig eXam sensoris not connected to the KaVo In eXam or is being operated in mixed-mode.

See also: 3.4.1 Attaching sensors to KaVo In eXam, Page 27

3.3.3 Data connection via USB 2.0

The sensor is connected to the machine via a USB 2.0 connection. The componentsare physically connected to each other via simple plug-fit connections. Anchoringthe KaVo trigger into the device on the X-ray generator establishes the physicalconnection between the machine and KaVo trigger or sensors. In accordance withUSB standards, the USB data connection may comprise up to four 5m sections.Hubs that are compliant with USB 2.0 must be used to connect up the individualsections

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Every hub that is directly connected to a KaVo sensor, i.e. withnoKaVo Dig eXamInterface, must be capable of supplying the requisite current. Asa rule, this means that a transformer will need to be used (also for laptops if neces‐sary).The requirements listed in the chapter "Standard conformity" must be complied with.


NoteWhen using 5 metre long USB-cables the the USB-connection must plugged di‐rectly into the so-called motherboard. Insertion in the USB ports that are within thePC on further cables, is not permitted.

NotePassive USB extension cords may not be used. The distances between two HUBsmay only be bridged with a cord 5 m or less.

3.3.4 Portability of KaVo Dig eXam

KaVo Dig eXam is can be transported from one location to another, in order toenable operation of the sensors in different treatment rooms.KaVo Dig eXam is thus excellently suited for a multi-user installation in dental clinicsor group practices.The handy size provides optimum flexibility and offers you independence whenusing the sensors on a day-to-day basis.

3.3.5 Holder system for sensor

The positions in which the sensor can be placed in the mouth are the same as thosefor classic radiology when using X-ray film.

A colour-coded XCP-DS holding system is supplied as standard to assist in thepositioning of KaVo Dig eXam sensors for the parallel/right-angle technique.

This system includes the following:▪ Blue holder for the anterior teeth▪ Yellow holder for the molar area▪ A red holder for bitewing radiographs▪ A green holder for endodontic use

NoteThe use of the retention system is shown on the poster that comes with the retentionsystem.

See also:7 Accessories and compatibility, Page 53

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3 Product description | 3.4 Integration in KaVo In eXam

3.4 Integration in KaVo In eXam

3.4.1 Attaching sensors to KaVo In eXam

KaVo Dig eXamSensors are specifically intended to be integrated withtheKaVo In eXam. In this case, the optional USB lead is separated from the KaVotrigger and the KaVo trigger is inserted directly into the prepared opening at the headof the X-ray machine. The detector itself is placed in its special holder on the KaVotrigger, meaning that it is always on hand for use by the dentist.

Position of KaVo Sensors on the device

KaVo Dig eXam then enables the sensor to be removed without switching off themachine, simply by pulling gently and placing in another room.

Storage in the RWT holder.

A Dig eXam sensor can be stored in the provided RWT holder on the In eXam.The sensor must have hygienic protection and be inserted in the desired variationof the RWT holding set.

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3 Product description | 3.4 Integration in KaVo In eXam

The prepared RWT holder can be inserted with the guide rod into the provide clipon the In eXam.

NoteKaVo recommends that this option only be used for temporary storage to preventdamage from bumps, etc.

3.4.2 Internal USB connection in the scissor arm

If the KaVo trigger is operated in conjunction with a KaVo In eXam machine, it isconnected to the system via a plug-fit connection at the X-ray emitter. This establi‐shes a USB connection to the machine or to KaVo Dig eXam, enabling the transferof data.

Technical background:KaVo X-ray machines are equipped with an internal USB line that leads directly totheKaVo Dig eXaminterface in the X-ray machine via the scissor arm.

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3 Product description | 3.5 Sensor holder

3.5 Sensor holder

A sensor holder belongs to the Dig eXam.It is fitted on the wall and is used for holding a sensor between treatments when theDig eXam-Sensor is not used together with the KaVo In eXam.

The sensor is held in the holder by a magnet.The sensor holder can be taken off the KaVo Trigger in this case and laid in thesensor tray.

3.5.1 Active Sensor holder

With the optionally obtainable Dig eXam interface Mat. no. 1.003.2363 the distanceto the PC or hub can be increased to a max. 5 m line length from the USB 2.0, forexample to place the IT components outside of the patient's environment.The interface in this case is mounted covered by the plastic part of the sensor holder,and the accessory line to the KaVo trigger is tightly connected to the arising activesensor holder.

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3 Product description | 3.5 Sensor holder

In addition, it is possible in this case to run the line under the wall surface from thesensor cover to the IT component.

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3 Product description | 3.6 Status icon and sensor status on the PC

3.6 Status icon and sensor status on the PC

Two icons are visible in the Windows system area (cut-out in the so-called taskbarnext to the system clock)The blue -Icon displays that the software interfaces between Dig eXam-Hard‐ware and VixWin-Software is loaded.The colour of the -Icon shows the availability of the Dig eXam-Systems connected.

NoteOther icons can be displayed dependent on the set up of the X-ray system. Theseicons refer to further KaVo or Gendex equipment and are described in the relevantdocumentation.

NoteThis area of the Windows desktop in which the status icons are show is a part ofthe so-called windows taskbar. Windows should be configured so that the statusicons are always visible when taking an X-ray. The configuration of the taskbar isdescribed in Windows Help.

The following is a list of all the possible statuses and their icons

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3 Product description | 3.6 Status icon and sensor status on the PC

When the icon is green, the electronics, sensor and connections are operating cor‐rectly.The sensor is ready to detect the x-rays.

When the icon is YELLOW, the electronics, sensor and connections are operatingcorrectly.The sensor is waiting for the exposure to be activated.

NoteIf you are using a system that is not connected to KaVo In eXam, the KaVo triggermust be used to activate the process and must be pressed before the X-ray is taken.If you are using a system that is connected to KaVo In eXam, activation occursautomatically once you start taking the X-ray.

The icon in RED status: Dig eXam is not connected to the PC and/or not ready totake an X-ray.

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3 Product description | 3.7 Technical Data

3.7 Technical Data

3.7.1 KaVo Dig eXam Sensors and Interface

Data connection USB 2.0Pixel size 18,5 µm / theoretical resolution 27 LP/

mmPixel binning 1 x 1System resolution typ. 18 LP/mm / min 16 LP/mm [at

200µGy, 60kV] > 50 µGyActive surface sensor size (3520) 30 x 22 mm2

Active surface sensor size II(3530) 36 x 27 mm2

kV range 60-70 kV

3.7.2 IT component requirements

Compliance with standards when instal‐ling IT components in patient surroun‐dings

IEC 60601-1:1988 +A1:1991 +A2:1995

Compliance with standards when instal‐ling IT components outside of patientsurroundings and using the Dig eXaminterface to connect the sensor.

IEC 60950-1:2001

Compliance with standards when instal‐ling IT components outside of patientsurroundings and connecting sensor di‐rectly without using the Dig eXam inter‐face.

IEC 60950-1: 2001 and a second pro‐tective conductor connection

Data interface for sensors USB 2.0, 500 mA, High SpeedData interface for Dig eXam InterfaceUSB 2.0(self-powered mode)

100 mA

Data interface for Dig eXam InterfaceUSB 2.0(bus-powered mode)

500 mA

Operating system Windows 2000 or Windows 2003 withmost up-to-date service pack, WindowsXP with most up-to-date service pack

Labelling European CE markingConnection of IT components to mainssupply

Use of portable multiple sockets is pro‐hibited.

NoteFurther information in theuser instructions VixWin PRO.

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3.7.3 Ambient conditions for KaVo Dig eXam sensors and interface[compliant with IEC601-1]

Operation

Air humidity Condensation is not permitted to form onthe machine; relative atmospheric humi‐dity 30-75%

Air pressure between 700 hPa and 1060 hPaAmbient temperature 10° to 40° Centigrade

Storage and transport

Air humidity relative Air humidity between 10% and95% (TBC uwezel)

Air pressure between 700 hPa and 1060 hPaUnpacked 5° to 70° centigradeIn original packaging -20° to 70° centigrade (short term up to

2h: -40° C to 85° centigrade)

3.7.4 Equipment classification

KaVo Dig eXam Sensors

▪ Class I– in accordance with EC Directive 93/42/EEC of June 14, 1993

▪ Application part type BF (IEC 601-1)– Not protected from the penetration of water [IP20].– Not suitable for sterilisation.– Suitable for wipe or surface disinfection using the cleansers described in the

instructions for use.– Not suitable for operation in environments with combustible mixtures.

KaVo active sensor holder

▪ Not protected from the penetration of water [IP20].▪ Not suitable for sterilisation.▪ Suitable for wipe or surface disinfection using the cleansers described in the

instructions for use.▪ Not suitable for operation in environments with combustible mixtures.

3.7.5 Conformity with standards


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3.7.6 Electrical connection

KaVo Dig eXam Sensors

DC voltage 5V [supply via USB 2.0]Max. power 500 mAData connection USB 2.0

KaVo active sensor holder

DC voltage 12V ±10 %Max. current 600 mAData connection USB 2.0 interfaceCompliance withpower supply standards

Must comply with IEC 60950-1:2001

Length of feeder < 20 m

NoteIn Europe, the manufacturer's CE marking on the power supply unit confirms thatrelevant power supply standards have been complied with.

3.7.7 Dimensions, mass (original packaging)

Size of packaging approx. 300 x 330 x 220 mm³Weight < 5 kg

3.7.8 Exposure times

KaVo Dig eXam sensors in conjunction with KaVo In eXam

Preset dose level of 5 (60 kV is recommended) in digital mode.

NoteThis recommended dosage is based on thresholds which are applicable for theFederal Republic of Germany and may need to be adjusted in accordance withrelevant country-specific regulations and/or individual diagnostic circumstances.

See also: User instructions KaVo In eXam.

KaVo Dig eXam sensors in conjunction with non-KaVo intraoral X-rayequipment

The dose must be preselected according to applicable national regulations (ALARAprinciple). The sensor can be operated over a wide dose range corresponding toISO film speed class F-20% up to speed class D.

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KaVo recommends that the sensors be operated at 60kV

3.7.9 Information on electromagnetic compatibility

Guidelines and manufacturer's declaration - electromagnetic emissi‐ons

In eXam is intended for use in an environment as stipulated below. The customeror user of In eXam should ensure that it is operated in an environment of this type.

Emissions measurements Conformity Electromagnetic environment - gui‐de

HF-emissions in accordance withinCISPR 11

Group 1 Dig eXam uses HF energy solely forits internal functions. Its HF radiati‐on is therefore very low, and it isunlikely that nearby devices will besubject to interference.

HF-emissions in accordance withCISPR 11

Class B Dig eXam is suitable for use in alldevices, including those used in do‐mestic environments and similarwhich are connected directly to apublic supply grid which also sup‐plies buildings which are used forresidence purposes.

Emissions of harmonic oscillationsin accordance with IEC61000-3-2

Class A Dig eXam is suitable for use in alldevices, including those used in do‐mestic environments and similarwhich are connected directly to apublic supply grid which also sup‐plies buildings which are used forresidence purposes.

Emissions of voltage fluctuations /flicker in accordance withIEC61000-3-3

Compliant Dig eXam is suitable for use in alldevices, including those used in do‐mestic environments and similarwhich are connected directly to apublic supply grid which also sup‐plies buildings which are used forresidence purposes.

Stability tests IEC 60601 - Test level Compliance level Electromagnetic environment - gui‐de

Discharge of staticelectricity in accor‐dance with IEC61000-4-2

+/- 6 kV Contact di‐scharge+/- 8 kV Air discharge

+/- 6 kV Contact di‐scharge+/- 8 kV Air discharge

Floors should be made of wood orconcrete or be covered with cera‐mic tiles If the floor is covered witha synthetic material, the relative airhumidity must be at least 30 %.

Rapid transient electri‐cal disturbances / burstin accordance with IEC61000-4-4

+/- 2 kV +/- 2 kV formains cables +/- 1 kVfor input and output ca‐bles

+/- 2 kV for mains ca‐bles+/- 1 kV for input andoutput cables

The quality of the supply voltageshould be equivalent to that of a ty‐pical business or hospital environ‐ment.

Surges in accordancewith IEC 61000-4-5

+/- 1 kV Normal modevoltage+/- 2 kV Common modevoltage

+/- 1 kV Common modevoltage+/- 2 kV Common modevoltage

The quality of the supply voltageshould be equivalent to that of a ty‐pical business or hospital environ‐ment.

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Stability tests IEC 60601 - Test level Compliance level Electromagnetic environment - gui‐de

Voltage drops, shortli‐ved interruptions undfluctuations in the sup‐ply voltage in accor‐dance with IEC61000-4-11

< 5 % UT (> 95 % dropin UT) for 1/2 period)40 % UT (60 % drop inUT) for 5 periods,70 % UT (30 % drop inUT) for 25 periods,< 5 % UT (> 95 % dropin UT) for 1/2 periods

< 5 % UT (> 95 % dropin UT) for 1/2 period)40 % UT (60 % drop inUT) for 5 periods,70 % UT (30 % drop inUT) for 25 periods,< 5 % UT (> 95 % dropin UT) for 1/2 period)

The quality of the supply voltageshould be equivalent to that of a ty‐pical business or hospital environ‐ment. When the user of Dig eXamdemands continuing function of thedevice even when the power supplyis interrupted, it is recommendedthat Dig eXam be powered via anuninterruptible power supply or abattery.

Magnetic field at thesupply frequency(50/60 Hz) in accor‐dance with IEC61000-4-8

3 A/m 3 A/m Magnetic fields at the mains fre‐quency should correspond to thetypical values found in businessand hospital environments.

Guidelines and manufacturer's declaration - electromagnetic stability

Dig eXam is intended for use in the electromagnetic environment stipulated below.The customer or user of In eXam should ensure that it is operated in an environmentof this type.

Stability tests IEC 60601 - test level Compliance level Electromagnetic environment - gui‐de

Directed HF disturban‐ces in accordance withIEC 61000-4-6Directed HF disturban‐ces in accordance withIEC 61000-4-3

3 Veff

150 kHz to 80 MHz3 V/m80 MHz to 2.5 GHz

3 V3 V/m

Portable and mobile radio equip‐ment should not be used near to IneXam or its cables, as the recom‐mended safe distance has beencalculated in accordance with theequation applicable for the trans‐mitting frequency.Recommended safe distance :d = 1,2 * P up to 800 MHzd = 2,3 * P for 800 MHz to 2.5 GHzwhere PA is the power rating of thetransmitter in watts (WA) accordingto information from the manufactu‐rer of the transmitter, and d is therecommended safe distance in me‐tes (m).The field intensity of stationary ra‐dio transmitters should, at all fre‐quencies according to local investi‐gations,a be lower than thecompliance levelB.Near to devices bearing the symbol

, interference is possible.

Comment:The higher frequency range is applicable at 80 MHz und 800 MHz.

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a The field intensity of stationary transmitters such as the base stations of radiotelephones and mobile land radio devices, amateur radio stations, AM and FMbroadcasting services or television transmitters cannot, in theory, be determinedprecisely in advance. To determine the electromagnetic environment in respect ofstationary transmitters, a study of the location should be considered.If the measured field intensity at the location in which Dig eXam is being used ex‐ceeds the compliance level above, care should be taken with Dig eXam to ensurethat it is functioning in accordance with regulations. If unusual performance featuresare noted, additional measures may be required, such as changing the alignmentor moving In eXam somewhere else.bThe field intensity should be less than 3 V/m over the frequency range 150 kHz to80 MHz.

Recommended safe distances between portable and mobile telecom‐munications equipment and Dig eXam

Dig eXam is intended for use in an electromagnetic environment in which HF dis‐turbances are checked The customer or user of In eXam can help to preventelectromagnetic disturbances by complying with the minimum distance betweenportable and mobile HF telecommunications equipment (transmitters) and In eXam,depending on the output power of the communication device, as stipulated below.

The table shows the necessary safe distance, as a function of the transmissionfrequency, in m:

Rated power of the trans‐mitter in W

150 kHz to 80 MHzD=1.2 * P

80 MHz to 800 MHzD=1.2 * P

800 MHz to 2.5 GHzD= 2.3 * P

0.01 0.12 0.12 0.230.1 0.38 0.38 0.731 1.2 1.2 2.310 3.8 3.8 7.3100 12 12 23

For transmitters for which the rated power is not shown in the table above, the dis‐tance can be determined using the equation belonging to the relevant column, whereP is the rated power of the transmitter in watts (W) according to information fromthe manufacturer of the transmitter.

NoteThese guidelines may not be applicable in all situations The propagation of elect‐romagnetic waves is affected by absorption and reflection due to buildings, objectsand people.

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3 Product description | 3.8 Dig eXam inspection service (only available in Germany)

3.8 Dig eXam inspection service (only available in Germany)

The function and calibration of connected devices, such as the monitor and X-raygenerator can be inspected and/or reconfigured via a separate service application(KaVo Dig eXam inspection service).

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4 Operation | 4.1 Configuration of the Dig eXam driver software

4 Operation

4.1 Configuration of the Dig eXam driver software

▶ Left click on the X-ray Icon, to open the configuration dialogue.

The configuration dialogue covers three areas that are activated via the selectiontab:▪ Information ("Information“)▪ Configuration ("Configure“)▪ Parameters ("Treatments“)

4.1.1 Selection Information

This dialog shows the software version of the interface between Dig eXam and Vix‐Win in the top part.The status of the connected sensors is shown in the middle area. When the DigeXam interface is activated in the Configure dialog, the status of the interface is alsoshown. By clicking the Update button, this information can be reentered by theWindows operating system.When the Dig eXam Interface is not used, click the button "Prepare Acquisition" inthe bottom area (instead of using the button on the KaVo trigger) or in mixed modeto prepare the device for taking an x-ray.

NoteThe button is only displayed in the "Use In eXam" mode when "Mixed mode" is alsoactive.

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4.1.2 Selection configuration

The upper part of the dialogue makes it possible to set the X-ray parameters thatare transferred automatically to VixWin.The system events (e.g. "Sensor covered", "In eXam switched off") to be displayedby the operating system in their own windows can be set in the bottom area of thedialogue window.

NoteThese data are used by the separate X-ray folder support program.

Without In eXam

By selecting the mode "Custom“ means that the user can specify standard valuesfor tube voltage (kV), the tube current (mA) and the exposure time (ms). Theseparameters are added to every X-ray produced using Dig eXam and can be dis‐played later in the VixWin-Software and if necessary adjusted to the parametersselected for the individual X-ray image.

Using In eXam

When using In eXam the exposure time of the current X-ray image is automaticallyrecognised by the system and added to the X-ray image taken using Dig eXam. Thepossible standard values can be preset for the values for the tube voltage (kV) andthe tube current (mA), in order to add these to the X-ray image as well. All threeparameters can be displayed in VixWin later and if necessary adjusted to the para‐meters selected for the individual X-ray image.

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Dig eXam as the exclusive image receptor

▶ -Deactivate the "Mixed mode" button.Each time In eXam is triggered, a sensor image is taken.

Dig eXam alternating with other image receptors

RequirementEach time before a sensor image is taken with Dig eXam, the system must assumea ready state by pressing the trigger button or the button "Prepare for exposure" toobtain a sensor image.

▶ Activate the "Mixed mode" button.

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4.1.3 Selection parameters

This dialogue enables the setting of the details that are used for displaying the X-ray image taken.

NoteIt is recommended that the parameters are not altered without consulting the tech‐nician and or KaVo Customer Services.

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4 Operation | 4.2 Taking a digital X-ray

4.2 Taking a digital X-ray

4.2.1 Overview

Taking an X-ray using KaVo Dig eXam together with VixWin PRO takes place in afew steps that are explained in detail in the following:▪ Start the program or toggle to it if already open▪ Select patient▪ Prepare and position sensor▪ Take X-ray▪ Form diagnosis from image▪ Accept X-ray

4.2.2 Activate programme and select patient

▶ Click the VixWin Pro-Software icon.

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or▶ Activate the program from the start menu

or▶ Call up VixWin Pro via the interface administration software used in the practice /

clinic.

VixWin PRO is active.

▶ Select patient.

See also: User instructionsVixWin PRO.

NoteIt is possible, as an alternative to the procedure described here, to take the X-rayfirst and then after taking the X-ray to allocate the X-ray to the patient.

4.2.3 Prepare and position sensor

Hygiene is a key issue during the preparation and taking of X-rays and must beconsidered alongside the issue of radiation protection.

Hygiene

To avoid health risks,KaVo sensors must be placed in a disposable hygienic pro‐tective cover before each use. So called hygienic covers are placed over the sensorbefore each treatment to guarantee the optimum levels of hygiene.

▶ Cover sensor with hygienic covers.▶ Use a new disposable hygienic sensor cover for every patient.

CAUTION

Risk of infectionContaminated sensors can transmit infections.▶ Your practice should have a set of hygiene procedures which must be adhered

to.▶ Disinfect sensors after contamination.▶ Disinfect the used parts of the right-angle holder ( XCP-DS) after contamination.▶ Always use hygienic covers Mat. no. 1.003.2690.

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Prepare the sensor with the hygiene sheet

See also: 6.1 Cleaning and disinfecting, Page 51

Right-angle holder set

CAUTION

Avoidable exposure to radiation.Increased exposure to radiation through not using a radiation field limitation facilityduring the right-angle technique.▶ Always use a right-angle holder and radiation field limitation facility unless there

is a contra-indication in a particular case.

The XCP DS holding system is supplied with an operating instruction poster. Forfurther explanations on X-raying techniques, please see related textbooks.

See also:Pasler, Friedrich A.: Zahnärztliche Radiologie (Dental Radiology), Thieme, 4th edi‐tion 2003, ISBN 3136046048Whaites, Eric: Essentials of Dental Radiography and Radiology (Dental Series),Churchill Livingstone 1996, ISBN 0443053499

Position KaVo Dig eXam

TheKaVo Dig eXamdetector is positioned at the X-ray tube head during use oftheKaVo In eXam so that it is always in close proximity to the patient's head.

Place the sensor

If you are usingKaVo Dig eXam with X-ray sources from other manufacturers, thepatient should either be given the KaVo trigger to hold or have it placed on theirchest.

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CAUTION

Faults as a result of disruption to the USB line.Breaking the connection between the KaVo trigger and USB line during use canlead to faults.▶ During use, never disconnect the KaVo trigger from the USB line!

CAUTION

Faults as a result of patient action.If patients are unsupervised during the X-ray procedure, they may do somethingthat results in a fault or disruption.▶ Ensure that patients are never left unsupervised during the X-ray procedure.

4.2.4 X-ray

▶ Position the X-ray source in accordance with the X-ray machine's operating in‐structions for the type of X-ray you are about to take.

CAUTION

X-ray radiation dangerIncreased exposure to radiation for patient and/or operator.▶ Adhere to the X-ray machine operating instructions and country-specific regu‐

lations governing patient protection.▶ Adhere to the X-ray machine operating instructions and country-specific regu‐

lations governing operator protection by keeping a safe distance or using ascreen.

Activate sensors (use eXam with other image receptors)

RequirementWhen using third-party x-ray equipment or when the mixed mode setting is activa‐ted to support the alternating use of other image receptors, activate the status"Ready to take x-rays".

▶ Press the KaVo trigger button.

KaVo Trigger

or

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▶ Select button "Repair Acquisition“ in the information area of the Dig eXam-driversoftware.

NoteThis step is not necessary for KaVo In eXam with activatedKaVo Dig eXam Inter‐face. KaVo Dig eXamis always ready to take an X-ray if the sensor is inserted onaccount of its permanent connection to the interface.

Visual inspection

Visual inspection

Before you take the X-ray, have a quick look to make sure that▪ The green icon is showing in the Windows System area▪ The patient has not moved at all▪ When using Dig eXam without In eXam-connection the ready dialogue is visible.

Sensor is activated (operation without In eXam connection)

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CAUTION

Image lost during the taking of X-rays.The X-ray will not take if the driver is not active.▶ Before taking an X-ray, make sure the software is ready.

▶ Take X-ray.

4.2.5 Conclude X-ray procedure

After you have finished taking the X-ray▪ Detach the holding system and sensor▪ Remove hygienic cover▪ Restore used holder▪ Restore contaminated sensor▪ When using non-KaVo X-ray sources, store the sensor in a safe place

4.2.6 Create a diagnosis based on the radiograph

See also: User instructions VixWin Pro.

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5 Maintenance/safety inspections | 5.1 Checks

5 Maintenance/safety inspections

5.1 Checks

The following checks must be made at the times specified▪ Monthly: Check the data backup function is running smoothly.▪ Annually: Perform a visual inspection of connection leads, wires and casing to

check for damage.

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6 Preparation methods DIN EN ISO 17664 | 6.1 Cleaning and disinfecting

6 Preparation methods DIN EN ISO 17664

CAUTION

Damage resulting from improper equipment preparationImproper cleaning and disinfection can lead to damage to the KaVo Dig eXam.▶ Adhere closely to the instructions provided in this section.▶ Use the correct substances and procedures for the job at hand.

6.1 Cleaning and disinfecting

NoteKaVo Dig eXam does not include any parts requiring sterilisation as part of theirintended use.

The sensor holder can be removed from the KaVo trigger for cleaning and disin‐fection.

NoteThe detector including the connecting line should be provided with a hygiene sheetto prevent direct contamination by the detector during use.

The sensors used within intraoral dentistry are highly sophisticated electronic devi‐ces. And as such should be handled with extreme care.▪ Before you begin cleaning and disinfecting, detach the sensors from the USB

connection.▪ Do not exert pressure on the sensors during the cleaning and disinfection pro‐

cedure; in particular, do not pull or bend their wires.▪ Do not entangle the KaVo trigger and USB line when connecting or disconnec‐

ting.▪ Do not allow moisture to penetrate the KaVo trigger and USB line plug-fit con‐

nections and the line's USB connector.

6.1.1 Cleaning

All external surfaces of the KaVo Dig eXam can be wiped with a soft cloth impreg‐nated with a mild cleaning fluid.The sensor holders and separate parts of the right-angle holder set can also bemachine-cleaned.

6.1.2 Disinfection

Disinfect contaminated parts of KaVo Dig eXam after use.

Wipe disinfection with disinfecting agents containing alcohol

All external surfaces of the KaVo Dig eXam can be wiped with a soft cloth impreg‐nated with a mild cleaning fluid.

The following disinfectant is permitted:▪ Elastoclean Spray 2

Manufacturer: KaVo Dental GmbH

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6 Preparation methods DIN EN ISO 17664 | 6.1 Cleaning and disinfecting

▪ MIKROZID Pump-SprayManufacturer: Schülke & Mayr

▪ Dürr System-Hygiene FD 322 SprühdesinfektionManufacturer: DÜRR Dental GmbH

▪ Incidin liquidManufacturer: Ecolab

▪ USA: Asepticare Aerosol SprayManufacturer: Ecolab

Prohibited disinfectants:▪ Phenol-based glutaraldehyde

Heat disinfection

When circumstances dictate, the sensor holder and separate parts of the right-angleholder set may be disinfected at 135°C in an autoclave in accordance with the ma‐nufacturer's instructions. The plastic parts must not be allowed to come into contactwith the autoclave walls.

Thermodisinfection/Miele

When circumstances dictate, the sensor holder and separate parts of the right-angleholder set may be heat disinfected (up to a maximum of 50 times) in a thermodi‐sinfector system, such as Miele's G 7781, in accordance with the manufacturer'sinstructions.

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7 Accessories and compatibility | 7.1 eXam Family

7 Accessories and compatibility

As a rule, KaVo recommends additional equipment from the eXam range.

7.1 eXam Family

KaVo Dig eXam belongs to the KaVo eXam intraoral X-ray system. The X-ray ma‐chine KaVo In eXam is available under no. Mat. no. 1.002.4800 .

Presentation Material summary Mat. no.Rectangular radiation field limi‐tation, max. radiation field 35 *45 mm²

1.003.0341

Rectangular radiation field limi‐tation, max. radiation field 35 *45 mm²

1.003.7200

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Presentation Material summary Mat. no.Test object for constancycheck, digital

1.003.0252

Test object for constancycheck, film

1.003.0250

Cable CCU/USB plug 1.003.1828

Hygienic covers 1.003.2690

sensor holder 1.002.4806

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Presentation Material summary Mat. no.eXam holder set for paralleltechnique

1.003.2676

Cone extension 30 cm 1.003.1576

Sensor holder 1.003.7203

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Presentation Material summary Mat. no.Sensor holder active 1.003.2363Kit for sensor holder on lightmount pole

1.003.0008

See also: the spare part sheet for the separate parts of the holding system.

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7 Accessories and compatibility | 7.2 Compatibility

7.2 Compatibility

7.2.1 Non-KaVo X-ray machines

KaVo Dig eXam is compatible with all X-ray machines whose intended purpose isto take dental intraoral radiographs, provided that these machines do not have do‐sage level settings which exceed film sensitivity class D.

CAUTION

Avoidable radiation exposureGreater radiation exposure from not observing the ALARA principle.▶ Apart from the technical suitability of the KaVo Dig eXam sensors for the doses

of film sensitivity D, use the smallest possible dose for each indication.

7.2.2 IT components

▪ Image viewers/monitors– The computer monitors must be suitable for the examination of radiographs.

Observe the relevant federal regulations. The provided test images can alsobe used for monitors that are only for showing radiographs.

▪ Printing out radiographs– The achievable quality of printouts greatly depends on the printer technology.

Printouts are generally unsuitable for diagnostics. X-ray images should ge‐nerally be diagnosed on suitable monitors.

The technical compatibility requirements of the USB components used to createradiographs have already been mentioned in the product description.

See also:3.7.2 IT component requirements , Page 332.4.4 Standard conformity, Page 18

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8 Troubleshooting | 7.2 Compatibility

8 Troubleshooting

The following table is a troubleshooting guide to help solve typical problems withoutrequiring any special technical training.The only precondition is that the KaVo Dig eXam has been installed correctly.

If you are unable to remedy your problem by following the solution methods pre‐sented here, please contact your responsible KaVo partner.

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8 Troubleshooting | 8.1 Symptoms, causes and solution

8.1 Symptoms, causes and solution

Malfunction Cause RemedyEverything has stopped working. Power supply interrupted. ▶ Make sure equipment is plugged

in at the mains.No image. Insufficient X-ray radiation. ▶ Increase X-ray radiation in ac‐

cordance with user instructions.See also: GA X-ray equipment

When using a non-KaVo X-ray ma‐chine: KaVo Icon red (Dig eXamwas not ready for capturing digitalimages).

▶ Make ready before triggering theX-ray radiation by activating(press the button on the KaVoTrigger).

Image is too dark. The exposure time is too long or theentry mode selected is not appro‐priate for Dig eXam.The entry mode selected does notmatch the X-ray dose.

▶ Reduce exposure time.See also: GA X-ray equipment

Radiograph is pale or contains in‐terference

The exposure time is too low. ▶ Increase exposure time.The image entry mode selecteddoes not match the configured X-ray dose.

▶ Consult X-ray emitter operatinginstructions.

The voltage set for the X-ray emitteris too low (< 60 kV).

▶ Inspect X-ray emitter.

The X-ray tube head is too far awayfrom the patient.

▶ Check the settings and positio‐ning and change if necessary.

Monitor is not positioned optimally. ▶ Check how the monitor is positi‐oned and alter its position if ne‐cessary.

Monitor settings are incorrect. ▶ Use appropriate test images totest your monitor settings.

The parameter settings for automa‐tic image display using VixWin PROhave been set to unsuitable values.

See also: VixWin Pro-user Instructi‐ons.See also: 4.1.3 Selection parame‐ters, Page 43

Radiograph is blurred Patient moved whilst X-ray wasbeing taken.

▶ Inform the patient of the problemand take another X-ray.

X-ray tube head was not fasteneddown securely enough or was mo‐ved whilst the X-ray was being ta‐ken.

▶ Check that the X-ray tube headis firmly in place and, if neces‐sary, use the software's filterfunction to improve image quali‐ty.

The radiograph is white X-ray dosage too low ▶ Increase the X-ray dosage.The active side of the sensor, whichis sensitive to radiation, was not di‐rected towards the radiation source.

▶ Direct X-ray tube head and sen‐sor.

Sensor not connected properly. ▶ Check connection.▶ Check that the X-ray emitter is

working.▶ If necessary, repeat the sensor

installation procedure.▶ If you have no success after

trying the above, please call theService team.

KaVo Icon stays red. In eXam switched off. ▶ Switch In eXam on.

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8 Troubleshooting | 8.1 Symptoms, causes and solution

Malfunction Cause RemedyWhen using a non-KaVo X-ray ma‐chine: KaVo Icon red (Dig eXamwas not ready for capturing digitalimages).

▶ Make ready before triggering theX-ray radiation by activating(press the button on the KaVoTrigger).

In eXam the configuration setting ofthe Dig eXam-driver software isdeactivated.

▶ Select In eXam in the configura‐tion area of the Dig eXam-driversoftware.

See also: 4.1.2 Using In eXam, Pa‐ge 41

The software connection betweenDig eXam-driver and the Windowsoperating system is faulty.

▶ Reset the software connectionbetween Dig eXam and Wind‐ows.To do this press the Update but‐ton in the configuration area ofthe Dig eXam-driver software.

See also: 4.1.1 Selection Informati‐on, Page 40▶ Reset the software connection

by pulling and reinserting theKaVo-Trigger.

▶ Shutdown the computer (switchoff completely) and then startagain.

The physical USB 2.0-connectionvia cables and or hubs between theKaVo Trigger and the computer isfaulty.

▶ Reinsert USB-plug.or▶ Insert the hub power supply

again.or▶ Have USB-2.0-cables checked

and if necessary replace dama‐ged cables.

or▶ Check the potential equalisation

between the PC and eXam.or▶ Call service technician/

The operating system asks for con‐firmation to activate the sensor dri‐ver.

▶ Confirm the relevant buttons foractivating the drivers queried bythe operating system.

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Documents

KaVo Dig eXam 3520, 3530 Instructions for use