Kavo In eXam 3520, In eXam 3530 User Manual

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 In eXam 3520, In eXam 3530 User Manual

Specifications and Main Features

Frequently Asked Questions

User Manual

Contents