Kavo In eXam 3520, In eXam 3530 User Manual

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Instructions for use KaVo Dig eXam 3520, 3530

Always be on the safe side.

Sales:

KaVo Dental GmbH Bismarckring 39 D-88400 Biberach Tel. +49 7351 56-0 Fax +49 7351 56-1488

Manufacturer:

Kaltenbach & Voigt GmbH Bismarckring 39 D-88400 Biberach www.kavo.com

Instructions for use KaVo Dig eXam 3520, 3530 Contents

Contents ...........................................................................................................................................................1

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

1.1 Intended users ......................................................................................................................................... 3

1.2 User guidelines ........................................................................................................................................ 4

1.2.1 Standard documentation ..................................................................................................................4

1.2.2 Abbreviations ...................................................................................................................................4

1.2.3 Symbols used ...................................................................................................................................5

1.2.4 Symbols on nameplates ................................................................................................................... 5

1.3 Service ..................................................................................................................................................... 6

1.4 Implied warranty ....................................................................................................................................... 7

1.5 Limitation of implied warranty ..................................................................................................................8

1.6 Transportation and storage ......................................................................................................................9

1.6.1 Transportation damage ....................................................................................................................9

1.6.2 Information on the packaging: Storage and transport ......................................................................9

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

2.1 Explanation of safety symbols ...............................................................................................................11

2.1.1 Hazard warning symbol ..................................................................................................................11

2.1.2 Explanation of different levels of hazard ........................................................................................11

2.1.3 Structure .........................................................................................................................................11

2.2 Intended purpose ................................................................................................................................... 12

2.2.1 General ..........................................................................................................................................12

2.2.2 Product-specific ..............................................................................................................................12

2.3 Safety symbols ....................................................................................................................................... 14

2.4 Prerequisite for proper technical operation ............................................................................................ 16

2.4.1 Data backup ...................................................................................................................................16

2.4.2 Sensor handling .............................................................................................................................17

2.4.3 Standards for IT-components .........................................................................................................18

2.4.4 Standard conformity .......................................................................................................................18

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

3.1 Entire system ......................................................................................................................................... 20

3.2 Where to affix the nameplates, power rating plates and caution labels .................................................21

3.2.1 Labeling ..........................................................................................................................................21

3.2.2 Symbols on identification labels .....................................................................................................23

3.3 Sensors ..................................................................................................................................................24

3.3.1 Installation sizes .............................................................................................................................24

3.3.2 KaVo Trigger ..................................................................................................................................25

3.3.3 Data connection via USB 2.0 .........................................................................................................25

3.3.4 Portability of KaVo Dig eXam ......................................................................................................... 26

3.3.5 Holder system for sensor ...............................................................................................................26

3.4 Integration in KaVo In eXam .................................................................................................................. 27

3.4.1 Attaching sensors to KaVo In eXam ..............................................................................................27

3.4.2 Internal USB connection in the scissor arm ...................................................................................28

3.5 Sensor holder ......................................................................................................................................... 29

3.5.1 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, 3530 Contents

3.7 Technical Data ....................................................................................................................................... 33

3.7.1 KaVo Dig eXam Sensors and Interface .........................................................................................33

3.7.2 IT component requirements ...........................................................................................................33

3.7.3 Ambient conditions for KaVo Dig eXam sensors and interface [compliant with IEC601-1] ............34

3.7.4 Equipment classification .................................................................................................................34

3.7.5 Conformity with standards ..............................................................................................................34

3.7.6 Electrical connection ......................................................................................................................35

3.7.7 Dimensions, mass (original packaging) .........................................................................................35

3.7.8 Exposure times ..............................................................................................................................35

3.7.9 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 ...................................................................................... 40

4.1.1 Selection Information .....................................................................................................................40

4.1.2 Selection configuration ................................................................................................................... 41

4.1.3 Selection parameters .....................................................................................................................43

4.2 Taking a digital X-ray ............................................................................................................................. 44

4.2.1 Overview ........................................................................................................................................44

4.2.2 Activate programme and select patient .......................................................................................... 44

4.2.3 Prepare and position sensor ..........................................................................................................45

4.2.4 X-ray ...............................................................................................................................................47

4.2.5 Conclude X-ray procedure .............................................................................................................49

4.2.6 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 .......................................................................................................................51

6.1.1 Cleaning .........................................................................................................................................51

6.1.2 Disinfection .....................................................................................................................................51

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

7.1 eXam Family .......................................................................................................................................... 53

7.2 Compatibility ..........................................................................................................................................57

7.2.1 Non-KaVo X-ray machines .............................................................................................................57

7.2.2 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 employees who are conversant with the taking, processing and archiving of computer-based intraoral X-rays on the Microsoft® Windows operating system . Prior to using the equipment, it assumed that users have been instructed in the use of KaVo Dig eXam-Sensors in accordance with the stipulations of the country in which they are practising, on the safe and proper use of X-ray radiation for the taking of intraoral dental X-rays.

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Instructions for use KaVo Dig eXam 3520, 3530 1 User notes | 1.2 User guidelines

1.2 User guidelines

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

This document has been translated from the German original.

Note Microsoft and Windows are registered trademarks of Microsoft Corporation and its registered 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 indicate that they are subject to unrestricted use. Every company logo or trademark men‐ tioned here is the sole property of the company mentioned. Brands, names and prices are given for information purposes only.

1.2.1 Standard documentation

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

– User instructions – Assembly instructions

▪ User instructions Software VixWin PRO.

1.2.2 Abbreviations

Abbrevia‐ tion ALARA "As low as reasonably achievable": The guiding principle behind radiation protection during the

EMC Electromagnetic compatibility UI User instructions Hub A central point: a distribution device that makes available a number of USB interfaces. IEC International Electrotechnical Commission AI Assembly instructions SQL "Structured Query Language": Standardised computer language for querying relational databases SFC Safety checks SW Software STI Service Technician's instructions USB Universal Serial Bus. Standardised means of connecting peripherals to personal computers.

Meaning

taking of X-rays, meaning that radiation doses for both workers and the public are typically kept lower than their regulatory limits.

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Instructions for use KaVo Dig eXam 3520, 3530 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 conform to the requirements of the pertinent EC directives (applicable European standards). CSA label

SN: Serial number REF: 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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Instructions for use KaVo Dig eXam 3520, 3530 1 User notes | 1.3 Service

1.3 Service

Service hotline: + 49 (0) 7351 56-2900 Service.Roentgen@kavo.com Please indicate the version number of the program. Additional information can be obtained at: www.kavo.com

For North America

KaVo Dental KaVo Technologies / Gendex Imaging 019 West Oakton Street Des Plaines, IL 60018-1884 USA +1 (847) 640-48 00

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Instructions for use KaVo Dig eXam 3520, 3530 1 User notes | 1.4 Implied warranty

1.4 Implied warranty

The KaVo end-user customer guarantee for the product named in the completion certificate guarantees that the product functions correctly and that there are no faults in the material or workmanship for a duration of 12 months following the purchase date, according to the following conditions: Following a reasonable complaint relating to defects or short delivery, KaVo will provide 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 default and gross negligence or intent, the latter only applies if there are no compelling legal provisions opposing it. KaVo shall not be liable for defects and their consequences, which occur as a result of normal normal wear and tear, or of improper cleaning and maintenance, nonobservance of the operating, maintenance or connection regulations; calcination or corrosion; a contaminated air or water supply; or chemical or electrical effects, which are non-standard or not permitted according to company regulations. As a general rule, this guarantee does not apply to lamps, glassware, rubber parts or the colour durability of synthetic materials. KaVo shall not be liable for defects or their consequences if they are likely to be a direct 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 produce the original.

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Instructions for use KaVo Dig eXam 3520, 3530 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 all KaVo 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 authorised dealer 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 Pro

user instructions

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Instructions for use KaVo Dig eXam 3520, 3530 1 User notes | 1.6 Transportation and storage

1.6 Transportation and storage

1.6.1 Transportation damage

Outside of Germany

Note KaVo 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 procedure below:

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 packaging upon 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.

Note If the recipient does not follow one of the above instructions, the damage will be held to have occurred after the delivery (according to . CMR law , section 5, Art.

30).

1.6.2 Information on the packaging: Storage and transport

Note Keep the packaging for returning the product for service or repairs .

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

Transport upright with the arrows pointing upwards

Fragile - protect against knocks

Keep dry

Maximum permitted stacking load

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Instructions for use KaVo Dig eXam 3520, 3530 1 User notes | 1.6 Transportation and storage

Temperature range

Humidity

Air pressure

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Instructions for use KaVo Dig eXam 3520, 3530 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 avoiding personal and property damage.

CAUTION indicates a hazardous situation that can lead to property damage or minor to mo‐

CAUTION

derate injury.

WARNING

DANGER

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

DANGER indicates a maximum hazardous situation that can directly cause serious injury or death.

2.1.3 Structure

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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Instructions for use KaVo Dig eXam 3520, 3530 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 impermissible to 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 use of the KaVo product for the intended purpose.

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

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

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.

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

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

2.2.2 Product-specific

Dig eXamtogether with VixWin PRO is intended for processing dental, intraoral Xrays. 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 which they are practising, on the safe and proper use of X-ray radiation for the taking of intraoral dental X-rays.

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

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Instructions for use KaVo Dig eXam 3520, 3530 2 Safety | 2.2 Intended purpose

Disposal of electronics

Note According to the EC Directive 2002/96 concerning electrical and electronic used devices, 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 dental supplier.

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Instructions for use KaVo Dig eXam 3520, 3530 2 Safety | 2.3 Safety symbols

2.3 Safety symbols

Ionising radiation Overexposure to X-ray radiation.

CAUTION

▶ The handler can and must take measures, in accordance with country-specific

legal stipulations, to minimise their personal dose of radiation!

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.

Injury caused by damaged sensors Damaged 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 operation Deflagration ▶ KaVo Dig eXam must not be operated when using ignitable mixtures.

Malfunctions from electromagnetic fields. The product meets the applicable requirements regarding electromagnetic fields. Given the complex interactions between equipment and cell phones, the product may 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 .

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

Loss of data when taking x-rays When the transmission of data from the KaVo Dig eXam sensor to the computer does not meet the USB 2.0 standard, data may be lost when taking x-rays due to the 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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Instructions for use KaVo Dig eXam 3520, 3530 2 Safety | 2.3 Safety symbols

Monitor image interference preventing accurate diagnosis The quality of the X-ray image displayed on screen is dependent both on the prac‐

CAUTION

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.

Note When 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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Instructions for use KaVo Dig eXam 3520, 3530 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 the

personnel 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 and

set up according to the descriptions of these components. ▪ KaVo Dig eXam is an electronic medical device, and is subject to the special

precautions necessary for EMC. KaVo Dig eXam may only be operated when it

has been installed according to the EMC instructions in the instructions for use

and installation. ▪ When setting up the unit, follow all the requirements of VDE 0751-1, "Repeated

tests and test before startup of electronic medical devices and systems - general

guidelines". ▪ 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 VDE

0100-560:1995. In other countries, follow the corresponding national specifica‐

tions.

CAUTION

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

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

KaVo Trigger

The KaVo trigger connects the X-ray image detector to the computer system via a USB 2.0 data path. This connection takes place in the X-ray device KaVo In eXamsimply by inserting the interface in the X-ray head and in the KaVo 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 to connect it directly to the computer using the accessory cable supplied. In this case a Dig eXAM sensor of one size can be exchanged with a sensor of another size by changing the trigger.

Note The accessory line is "Pull/Push“-Connection. It must not be twisted when pulled out and plugged in.

when changing the Dig eXam Sensor from machine to machine or for another sensor size, 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 sensor is 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 components are physically connected to each other via simple plug-fit connections. Anchoring the KaVo trigger into the device on the X-ray generator establishes the physical connection between the machine and KaVo trigger or sensors. In accordance with USB 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 individual sections

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Instructions for use KaVo Dig eXam 3520, 3530 3 Product description | 3.3 Sensors

Every hub that is directly connected to a KaVo sensor, i.e. with noKaVo Dig eXamInterface, must be capable of supplying the requisite current. As a 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.

See also: 2.4.4 Standard conformity, Page 18

Note When 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 the PC on further cables, is not permitted.

Note Passive USB extension cords may not be used. The distances between two HUBs may 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 to enable operation of the sensors in different treatment rooms. KaVo Dig eXam is thus excellently suited for a multi-user installation in dental clinics or group practices. The handy size provides optimum flexibility and offers you independence when using 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 those for classic radiology when using X-ray film.

A colour-coded XCP-DS holding system is supplied as standard to assist in the positioning 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

Note The use of the retention system is shown on the poster that comes with the retention system.

See also: 7 Accessories and compatibility, Page 53

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Instructions for use KaVo Dig eXam 3520, 3530 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 with theKaVo In eXam. In this case, the optional USB lead is separated from the KaVo trigger and the KaVo trigger is inserted directly into the prepared opening at the head of the X-ray machine. The detector itself is placed in its special holder on the KaVo trigger, 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 the machine, 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 variation of the RWT holding set.

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Instructions for use KaVo Dig eXam 3520, 3530 3 Product description | 3.4 Integration in KaVo In eXam

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

Note KaVo recommends that this option only be used for temporary storage to prevent damage 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 is connected 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 transfer of data.

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

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Instructions for use KaVo Dig eXam 3520, 3530 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 the Dig 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 the sensor tray.

3.5.1 Active Sensor holder

With the optionally obtainable Dig eXam interface Mat. no. 1.003.2363 the distance to the PC or hub can be increased to a max. 5 m line length from the USB 2.0, for example 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 active sensor holder.

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Instructions for use KaVo Dig eXam 3520, 3530 3 Product description | 3.5 Sensor holder

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

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Instructions for use KaVo Dig eXam 3520, 3530 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 taskbar next 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.

Note Other icons can be displayed dependent on the set up of the X-ray system. These icons refer to further KaVo or Gendex equipment and are described in the relevant documentation.

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

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

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Instructions for use KaVo Dig eXam 3520, 3530 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 operating correctly. The sensor is waiting for the exposure to be activated.

Note If you are using a system that is not connected to KaVo In eXam, the KaVo trigger must 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 occurs automatically once you start taking the X-ray.

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

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Instructions for use KaVo Dig eXam 3520, 3530 3 Product description | 3.7 Technical Data

3.7 Technical Data

3.7.1 KaVo Dig eXam Sensors and Interface

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

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

Active surface sensor size (3520) 30 x 22 mm Active surface sensor size II(3530) 36 x 27 mm kV range 60-70 kV

3.7.2 IT component requirements

200µGy, 60kV] > 50 µGy

Compliance with standards when instal‐

IEC 60601-1:1988 +A1:1991 +A2:1995 ling IT components in patient surroun‐ dings

Compliance with standards when instal‐

IEC 60950-1:2001 ling IT components outside of patient surroundings and using the Dig eXam interface to connect the sensor.

Compliance with standards when instal‐ ling IT components outside of patient

IEC 60950-1: 2001 and a second pro‐

tective conductor connection surroundings and connecting sensor di‐ rectly without using the Dig eXam inter‐ face.

Data interface for sensors USB 2.0, 500 mA, High Speed Data interface for Dig eXam Interface

100 mA USB 2.0 (self-powered mode)

Data interface for Dig eXam Interface

500 mA USB 2.0 (bus-powered mode)

Operating system Windows 2000 or Windows 2003 with

most up-to-date service pack, Windows

XP with most up-to-date service pack Labelling European CE marking Connection of IT components to mains

supply

Use of portable multiple sockets is pro‐

hibited.

Note Further information in theuser instructions VixWin PRO.

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Instructions for use KaVo Dig eXam 3520, 3530 3 Product description | 3.7 Technical Data

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 on

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

Storage and transport

Air humidity relative Air humidity between 10% and

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

the machine; relative atmospheric humi‐

dity 30-75%

95% (TBC uwezel)

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

See also: 2.4.4 Standard conformity, Page 18

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Instructions for use KaVo Dig eXam 3520, 3530 3 Product description | 3.7 Technical Data

3.7.6 Electrical connection

KaVo Dig eXam Sensors

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

KaVo active sensor holder

DC voltage 12V ±10 % Max. current 600 mA Data connection USB 2.0 interface Compliance with

power supply standards Length of feeder < 20 m

Must comply with IEC 60950-1:2001

Note In Europe, the manufacturer's CE marking on the power supply unit confirms that relevant power supply standards have been complied with.

3.7.7 Dimensions, mass (original packaging)

Size of packaging approx. 300 x 330 x 220 mm³ Weight < 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.

Note This recommended dosage is based on thresholds which are applicable for the Federal Republic of Germany and may need to be adjusted in accordance with relevant 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-ray equipment

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

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Instructions for use KaVo Dig eXam 3520, 3530 3 Product description | 3.7 Technical Data

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 customer or 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 within CISPR 11

HF-emissions in accordance with CISPR 11

Emissions of harmonic oscillations in accordance with IEC61000-3-2

Emissions of voltage fluctuations / flicker in accordance with IEC61000-3-3

Group 1 Dig eXam uses HF energy solely for

its internal functions. Its HF radiati‐

on is therefore very low, and it is

unlikely that nearby devices will be

subject to interference.

Class B Dig eXam is suitable for use in all

devices, including those used in do‐

mestic environments and similar

which are connected directly to a

public supply grid which also sup‐

plies buildings which are used for

residence purposes.

Class A Dig eXam is suitable for use in all

devices, including those used in do‐

mestic environments and similar

which are connected directly to a

public supply grid which also sup‐

plies buildings which are used for

residence purposes.

Compliant Dig eXam is suitable for use in all

devices, including those used in do‐

mestic environments and similar

which are connected directly to a

public supply grid which also sup‐

plies buildings which are used for

residence purposes.

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

de Discharge of static electricity in accor‐ dance with IEC 61000-4-2

Rapid transient electri‐ cal disturbances / burst in accordance with IEC 61000-4-4 Surges in accordance with IEC 61000-4-5

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

+/- 2 kV +/- 2 kV for mains cables +/- 1 kV for input and output ca‐ bles +/- 1 kV Normal mode voltage +/- 2 kV Common mode voltage

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

+/- 2 kV for mains ca‐ bles +/- 1 kV for input and output cables +/- 1 kV Common mode voltage +/- 2 kV Common mode voltage

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Floors should be made of wood or

concrete or be covered with cera‐

mic tiles If the floor is covered with

a synthetic material, the relative air

humidity must be at least 30 %.

The quality of the supply voltage

should be equivalent to that of a ty‐

pical business or hospital environ‐

ment.

The quality of the supply voltage

should be equivalent to that of a ty‐

pical business or hospital environ‐

ment.

Instructions for use KaVo Dig eXam 3520, 3530 3 Product description | 3.7 Technical Data

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

de Voltage drops, shortli‐ ved interruptions und fluctuations in the sup‐ ply voltage in accor‐ dance with IEC 61000-4-11

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

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

The quality of the supply voltage

should be equivalent to that of a ty‐

pical business or hospital environ‐

ment. When the user of Dig eXam

demands continuing function of the

device even when the power supply

is interrupted, it is recommended

that Dig eXam be powered via an

uninterruptible power supply or a

battery. Magnetic field at the supply frequency (50/60 Hz) in accor‐ dance with IEC

3 A/m 3 A/m Magnetic fields at the mains fre‐

quency should correspond to the

typical values found in business

and hospital environments. 61000-4-8

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 environment of this type.

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

de Directed HF disturban‐ ces in accordance with IEC 61000-4-6 Directed HF disturban‐ ces in accordance with IEC 61000-4-3

3 V

eff

150 kHz to 80 MHz 3 V/m 80 MHz to 2.5 GHz

3 V 3 V/m

Portable and mobile radio equip‐

ment should not be used near to In

eXam or its cables, as the recom‐

mended safe distance has been

calculated in accordance with the

equation applicable for the trans‐

mitting frequency.

Recommended safe distance :

d = 1,2 *

up to 800 MHz

d = 2,3 * P for 800 MHz to 2.5 GHz

where PA is the power rating of the

transmitter in watts (WA) according

to information from the manufactu‐

rer of the transmitter, and d is the

recommended 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 the

compliance 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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Instructions for use KaVo Dig eXam 3520, 3530 3 Product description | 3.7 Technical Data

The field intensity of stationary transmitters such as the base stations of radio telephones and mobile land radio devices, amateur radio stations, AM and FM broadcasting services or television transmitters cannot, in theory, be determined precisely in advance. To determine the electromagnetic environment in respect of stationary 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 ensure that it is functioning in accordance with regulations. If unusual performance features are noted, additional measures may be required, such as changing the alignment or moving In eXam somewhere else.

The field intensity should be less than 3 V/m over the frequency range 150 kHz to 80 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 prevent electromagnetic disturbances by complying with the minimum distance between portable 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 transmission frequency, in m:

Rated power of the trans‐ mitter in W

150 kHz to 80 MHz

D=1.2 *

80 MHz to 800 MHz D=1.2 *

800 MHz to 2.5 GHz D= 2.3 *

0.01 0.12 0.12 0.23

0.1 0.38 0.38 0.73 1 1.2 1.2 2.3 10 3.8 3.8 7.3 100 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, where P is the rated power of the transmitter in watts (W) according to information from the manufacturer of the transmitter.

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

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Instructions for use KaVo Dig eXam 3520, 3530 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-ray generator can be inspected and/or reconfigured via a separate service application (KaVo Dig eXam inspection service).

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Instructions for use KaVo Dig eXam 3520, 3530 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 selection tab: ▪ 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 Dig eXam interface is activated in the Configure dialog, the status of the interface is also shown. By clicking the Update button, this information can be reentered by the Windows operating system. When the Dig eXam Interface is not used, click the button "Prepare Acquisition" in the bottom area (instead of using the button on the KaVo trigger) or in mixed mode to prepare the device for taking an x-ray.

Note The button is only displayed in the "Use In eXam" mode when "Mixed mode" is also active.

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Instructions for use KaVo Dig eXam 3520, 3530 4 Operation | 4.1 Configuration of the Dig eXam driver software

4.1.2 Selection configuration

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

Note These 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 values for tube voltage (kV), the tube current (mA) and the exposure time (ms). These parameters 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 parameters selected for the individual X-ray image.

Using In eXam

When using In eXam the exposure time of the current X-ray image is automatically recognised by the system and added to the X-ray image taken using Dig eXam. The possible standard values can be preset for the values for the tube voltage (kV) and the tube current (mA), in order to add these to the X-ray image as well. All three parameters 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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Instructions for use KaVo Dig eXam 3520, 3530 4 Operation | 4.1 Configuration of the Dig eXam driver software

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

Requirement Each time before a sensor image is taken with Dig eXam, the system must assume a ready state by pressing the trigger button or the button "Prepare for exposure" to obtain a sensor image.

▶ Activate the "Mixed mode" button.

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Instructions for use KaVo Dig eXam 3520, 3530 4 Operation | 4.1 Configuration of the Dig eXam driver software

4.1.3 Selection parameters

This dialogue enables the setting of the details that are used for displaying the Xray image taken.

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

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Instructions for use KaVo Dig eXam 3520, 3530 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 a few 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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Instructions for use KaVo Dig eXam 3520, 3530 4 Operation | 4.2 Taking a digital X-ray

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.

Kavo In eXam 3520, In eXam 3530 User Manual

Specifications and Main Features

Frequently Asked Questions

User Manual

Contents

KaVo Trigger