Kavo In eXam 3510 User Manual

Instructions for use KaVo In eXam 3510

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 In eXam 3510 Contents

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

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

1.1 User guidelines .........................................................................................................................................3

1.1.1 Standard documentation ..................................................................................................................3

1.1.2 Abbreviations ....................................................................................................................................3

1.1.3 Symbols used ...................................................................................................................................3

1.1.4 Definitions .........................................................................................................................................5

1.2 Target audience .......................................................................................................................................6

1.3 Service .....................................................................................................................................................7

1.3.1 For North America ............................................................................................................................7

1.4 Implied warranty .......................................................................................................................................8

1.5 Restrictions on the guarantee ..................................................................................................................9

1.6 Transport and storage ............................................................................................................................10

1.6.1 Transportation damage ..................................................................................................................10

1.6.2 Storage ...........................................................................................................................................10

2 Safety ...........................................................................................................................................................12

2.1 Explanation of safety symbols ................................................................................................................12

2.1.1 Warning symbol ..............................................................................................................................12

2.1.2 Structure .........................................................................................................................................12

2.1.3 Description of danger levels ...........................................................................................................12

2.2 Intended purpose ...................................................................................................................................13

2.2.1 General ...........................................................................................................................................13

2.2.2 Product-specific ..............................................................................................................................14

2.3 Safety instructions ..................................................................................................................................15

2.3.1 Attaching to KaVo Primus 1058 ......................................................................................................16

2.4 Protective devices ..................................................................................................................................17

2.4.1 Closing the casing ..........................................................................................................................17

2.5 Requirements for correct operation ........................................................................................................18

2.5.1 Standard conformity .......................................................................................................................18

3 Product description ......................................................................................................................................19

3.1 Entire system ..........................................................................................................................................19

3.2 Operating unit .........................................................................................................................................20

3.2.1 Assignment of button/area to be X-rayed .......................................................................................20

3.3 Focal spot determination ........................................................................................................................22

3.4 Where to affix nameplates, power rating plates and caution labels .......................................................23

3.5 Nameplates, power rating plates and caution labels ..............................................................................24

3.6 Technical data ........................................................................................................................................28

3.6.1 Information on electromagnetic compatibility .................................................................................32

3.6.2 Standard conformity .......................................................................................................................35

3.7 Determination of the patient's X-ray exposure .......................................................................................36

3.7.1 Exposure diagram ..........................................................................................................................36

4 Operation .....................................................................................................................................................37

4.1 Switch on machine .................................................................................................................................37

4.2 Specifying the imaging parameters ........................................................................................................38

4.3 Laser highlighting of central beam .........................................................................................................39

4.4 Positioning patients ................................................................................................................................40

4.5 Position X-ray source .............................................................................................................................41

4.6 Positioning the image receiver ...............................................................................................................42

4.7 Take X-ray ..............................................................................................................................................45

4.8 Finishing off activities .............................................................................................................................46

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Instructions for use KaVo In eXam 3510 Contents

5 Setting default doses, film sensitivity and sensor sensitivity ........................................................................47

5.1 Correction of the exposure time / dose default setting ...........................................................................47

5.2 Selection of the suitable basic dose .......................................................................................................48

5.2.1 With film ..........................................................................................................................................48

5.2.2 With digital image receiver .............................................................................................................48

5.3 Exposure time table ................................................................................................................................49

5.3.1 Default dose setting for X-rays taken using film .............................................................................49

5.3.2 Default dose for X-rays taken with digital image receivers .............................................................52

6 Preparation methods DIN EN ISO 17664 ....................................................................................................56

6.1 Cleaning and disinfection .......................................................................................................................56

6.1.1 Cleaning .........................................................................................................................................56

6.1.2 Disinfection .....................................................................................................................................56

7 Safety checks ...............................................................................................................................................58

8 Troubleshooting ...........................................................................................................................................59

9 Accessories and compatibility ......................................................................................................................62

9.1 Accessories and kits ...............................................................................................................................62

9.1.1 Accessories ....................................................................................................................................62

9.1.2 Kits ..................................................................................................................................................63

9.2 Compatibility ...........................................................................................................................................64

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Instructions for use KaVo In eXam 3510 1 User notes | 1.1 User guidelines

1 User notes

1.1 User guidelines

Requirement You should read these instructions prior to installing the product, in order to avoid maloperations and damage.

This document has been translated from the German original.

1.1.1 Standard documentation

The product-related documentation forKaVo In eXam consists of the following com‐ ponents. You can order more of these from KaVo, if necessary: ▪ User instructions ▪ Assembly instructions ▪ Customer documents

1.1.2 Abbreviations

Short form GA Instructions for use PA Care instructions MA Assembly instructions TA Technician's instructions STK Safety check IEC International Electrotechnical Commission RA Repair instructions EMC Electromagnetic compatibility

Explanation

1.1.3 Symbols used

Symbols in this document

See the section Safety/Warning Symbol

Important information for users and technicians

Caution: ionising radiation!

Laser beam

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Instructions for use KaVo In eXam 3510 1 User notes | 1.1 User guidelines

CE mark (Communauté Européenne). A product with this mark meets the requirements of the relevant EC directives, i.e. the applicable standards in Europe. Action request

Symbols on the operating unit and X-ray head

kV button

"Consult user instructions!" symbol

Take X-ray

Bitewing function area "Molars"

Bitewing function area "Canines/Incisors"

X-ray emission pilot lamp

Dig eXam button Dosage preselection film (7mA), digital image receivers (4mA).

Adult/child selection button

Occlusal function selection

Selection button for default dose setting "Ionising radiation" symbol

Symbols on identification labels

Type B application part [IEC 878-02-02]

Focus size [IEC 417-5326-a]

CE marking

X-ray filtration [IEC 417-5381]

X-ray tube CE marking [IEC 417-5381]

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Instructions for use KaVo In eXam 3510 1 User notes | 1.1 User guidelines

CSA label

Consult user instructions

For information about proper disposal, see intended purpose

1.1.4 Definitions

Definition Meaning Focus-skin distance (FSD) ① refers to the distance between the focal spot and the patient's skin. The focal spot is loca‐ ted at the point where both axes inter‐ cept, identified by the focal spot markers ② .

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Instructions for use KaVo In eXam 3510 1 User notes | 1.2 Target audience

1.2 Target audience

This document is intended for use by dentists and other practice employees as well as for use by clinic staff, who possess the appropriate 'expert knowledge' and who have undergone instruction on the use of X-ray machines in accordance with the stipulations of the country in which they are practising.

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Instructions for use KaVo In eXam 3510 1 User notes | 1.3 Service

1.3 Service

Service hotline: ++ 49 (0) 7351 56-2900 Service.Roentgen@kavo.com Please indicate the product serial number in all requests. Additional information can be obtained at: www.kavo.com

1.3.1 For North America

GENDEX Dental Systems 019 West Oakton Street Des Plaines, IL 60018-1884 USA +1 (847) 640-48 00

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Instructions for use KaVo In eXam 3510 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 In eXam 3510 1 User notes | 1.5 Restrictions on the guarantee

1.5 Restrictions on the guarantee

KaVo shall assume responsibility for the safety, reliability and performance of all KaVo system components provided that: ▪ Assembly, upgrades, new settings, modifications or repairs toKaVo In eXam

exclusively carried out be KaVo or third parties authoirsed by KaVo forKaVo In eXam .

▪ The system has been installed and operated in accordance with the User in‐

structions and Assembly instructions.

▪ All servicing is performed in full compliance withDIN VDE-0751-1 must be com‐

plied with to its full extent.

▪ In Germany, the location in whichKaVo In eXam is installed is compliant with

standardsDIN VDE 0100-710: 2002-11 andVDE 0100-560:1995 in its design. In other countries, the corresponding national regulations must be respected.

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Instructions for use KaVo In eXam 3510 1 User notes | 1.6 Transport and storage

1.6 Transport 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 Storage

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

Temperature range

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Instructions for use KaVo In eXam 3510 1 User notes | 1.6 Transport and storage

Humidity

Air pressure

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Instructions for use KaVo In eXam 3510 2 Safety | 2.1 Explanation of safety symbols

2 Safety

2.1 Explanation of safety symbols

2.1.1 Warning symbol

Warning symbol

2.1.2 Structure

The introduction describes the type and source of the hazard. This section describes the potential consequences of non-observance.

DANGER

▶ The optional step contains necessary measures for avoiding hazards.

2.1.3 Description of danger levels

CAUTION

WARNING

DANGER

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‐ derate injury.

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.

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Instructions for use KaVo In eXam 3510 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.

To guarantee constant readiness for use and maintenance of value of the KaVo product, the recommended annual servicing must be done. Yearly safety inspections are required.

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

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Instructions for use KaVo In eXam 3510 2 Safety | 2.2 Intended purpose

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.

Note The waste that arises must be recycled or disposed of in a manner safe for humans and the environment. Observe the applicable national regulations. Please direct all questions regarding the proper disposal of KaVo products to the nearest KaVo branch.

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.

2.2.2 Product-specific

KaVo In eXam is an intraoral X-ray machine.

KaVo In eXam complies with all regulations that are in effect for X-ray and radiation protection. During use, diagnostic X-ray radiation is generated that could harm patients or third parties if incorrectly used. Compliance with the national quality assurance regulations that are in place, parti‐ cularly those relating to the operator/handler minimising exposure to high doses, is mandatory.

KaVo In eXam has a class 2 laser for making the X-ray's central beam visible. Cor‐ respondingly, the pertinentIEC 825-1 andIEC 60825-1 regulations have to be con‐ sulted.

X-ray machine disposal

The x-ray tube head contains materials whose disposal must be clarified after the device stops being used. Follow national regulations (consult your dental supplier if necessary). This concerns the systems that generate radiation (tubes, lead sheath), and all electronic components.

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Instructions for use KaVo In eXam 3510 2 Safety | 2.3 Safety instructions

2.3 Safety instructions

Radiation damage due to improper installation Unnecessary overexposure to X-ray radiation.

CAUTION

▶ Only individuals who have completed a relevant KaVo In eXam training course

are permitted to undertake assembly, upgrade, tuning or repair activities.

▶ Consult the country-specific regulations, guidelines and laws that are in place

to regulate the installation and operation of X-ray equipment.

Ionising radiation Overexposure 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!

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 .

CAUTION

WARNING

CAUTION

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

Injury or damage from damaged functional parts. When functional parts are damaged, it can cause additional damage or personal injury. ▶ When operating parts are damaged: Stop working and eliminatethe damage,

or notify a service technician.

▶ Check the electrode lines and accessories for damage to the insulation.

Laser beam (class 2) Looking directly into the laser beam can cause irritation or permanent changes. ▶ Do not look directly into the laser beam. ▶ Instruct patients not to do this either. ▶ Proceed with caution when positioning the X-ray tube head, switching the laser

off if necessary!

Ignition of ignitable mixtures due to electric equipment in operation. Deflagration ▶ The In eXam machine must not be operated when using ignitable mixtures.

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Instructions for use KaVo In eXam 3510 2 Safety | 2.3 Safety instructions

2.3.1 Attaching to KaVo Primus 1058

Risk of injury from falling or broken parts Safety and compliance with standards for the installation of In eXam in KaVo Pri‐

CAUTION

mus 1058 can be impaired if the parts supplied as standard in the kit were not installed in line with the assembly instructions. ▶ Make sure you follow the procedure described in the separate assembly in‐

structions for the kit!

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Instructions for use KaVo In eXam 3510 2 Safety | 2.4 Protective devices

2.4 Protective devices

The casing components of KaVo In eXam 3510 are securely fastened with concea‐ led, mounted nuts to safely prevent anybody from accidentally coming into contact with electrically charged components. These nuts can only be unscrewed by a qualified Service Technician.

2.4.1 Closing the casing

By pulling on the housing the wall cover or X-ray head casing can be detached from the snap-fit fastenings, so that a 5mm-wide opening can be seen. To close the casing, push the relevant part to fix it back into place.

Fix wall panel cover back on

▶ Using both hands, carefully push the wall panel cover to lock it back in place.

The cover is locked securely back in place.

Fix X-ray head cover back on

▶ Using both hands, carefully push the X-ray head cover to lock it back in place.

The cover is locked securely back in place.

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Instructions for use KaVo In eXam 3510 2 Safety | 2.5 Requirements for correct operation

2.5 Requirements for correct operation

The X-ray machine has to be installed in such a way as to make it impossible for anyone other than authorised individuals to take an X-ray.

Responsibility is assumed for the safety, reliability and performance of the unit 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. ▪ 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 In 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.

▪ The KaVo In eXam is an electronic medical device, and is subject to the special

precautions necessary for EMC. The KaVo In eXam may only be operated when it has been installed according to the EMC instructions in the instructions for installation.

CAUTION

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 3510 User Manual

Specifications and Main Features

Frequently Asked Questions

User Manual

Contents

Warning symbol