Kavo In eXam 3510 User Manual

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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.

See also: 3.2 Operating unit, Page 20

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Instructions for use KaVo In eXam 3510

56468513

Kaltenbach & Voigt GmbH

TRX 708, manufactored for KaVo SN:

0.7 [IEC 60336:1993]

2.5 mm Al 70kV Total filtration

60/70 kV 4/ 7 mA DC

Tube / HV Housing Assembly

TYPE: 3510 [230V] SN: YYYY-

This product complies with FDA regulation 21 CFR Subchapter J at the date of manufacture

21651

55555555

Kaltenbach & Voigt GmbH

60/70 kV 4/ 7 mA DC

TRX 708, manufactored for KaVo SN:

0.7 [IEC 60336:1993]

2.5 mm Al 70kV Total filtration

Tube / HV Housing Assembly

TYPE: 3510 [110V] SN: YYYY-

This product complies with FDA regulation 21 CFR Subchapter J at the date of manufacture

88888

88888888

Kaltenbach & Voigt GmbH

SN:

This product complies with FDA regulation 21 CFR Subchapter J at the date of manufacture

Radiation Area: max. Ø 60mm @ 200mm Focal distance

Beam Limiting 200mm

TYPE:

3510 YYYY-

3 Product description | 3.5 Nameplates, power rating plates and caution labels

3.5 Nameplates, power rating plates and caution labels

Position number with plate name Plate ①Rating plate for entire machine, 230 V

①Rating plate for entire machine, 110 V

②X-ray tube head plate 230 V

②X-ray tube head plate 110 V

③Shielding system for 200 mm focus/skin distance

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Instructions for use KaVo In eXam 3510

88888888

Kaltenbach & Voigt GmbH

REF:

SN:

Timer Unit

TYPE:

1.002.8217

3510 YYYY-

3 Product description | 3.5 Nameplates, power rating plates and caution labels

Position number with plate name Plate ⑥ Plate for operating unit

⑦ Laser warning plate

⑧ X-ray caution label USA

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Instructions for use KaVo In eXam 3510 3 Product description | 3.5 Nameplates, power rating plates and caution labels

⑨Rectangular aperture Size 35 * 45 mm² (shown here as example), black Size 27 * 37 mm² (not shown), blue

⑩Tube extension to 300 mm focus/skin distance

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]

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Instructions for use KaVo In eXam 3510 3 Product description | 3.5 Nameplates, power rating plates and caution labels

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

CSA label

Consult user instructions

For information about proper disposal, see intended purpose

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Instructions for use KaVo In eXam 3510 3 Product description | 3.6 Technical data

3.6 Technical data

Ambient conditions

Permissible operating temperature min. 10°C, max. 40°C Humidity No condensate may form on the device;

Storage min. 5°C, max. 70°C

Transport and storage conditions in the original packaging

Temperature min. -20°C, max. +70°C Air humidity min: 5 % max: 95 % Air pressure 700 – 1060 hPa

relative humidity of 30% - 75%.

Equipment classification

CE directive 93/42/EEC Class IIb product IEC 601-1:Type of protection from elec‐

tric shock IEC 601-1: Degree of protection from

electric shock IEC 601-1: Continuous operation with

high radiation exposure

Suitable and not suitable: ▪ Not protected from the penetration of water. ▪ 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.

Device belongs to protection class I

Type B application part

Intermittent operation

Electricity supply variant with a rated voltage of 230V

Alternating voltage 230 V; ± 10% (207 V – 253 V) Nominal frequency 50 Hz Max. current 5A Permissible impedance 0.5 Ohms Cross-section of the power line Up to a max. 16 m long: 1.5 mm² (or

AWG14); the diameter must be greater if the line is any longer.

Design of the mains power input Nominal voltage 250 V, corresponding to

applicable national regulations

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Instructions for use KaVo In eXam 3510 3 Product description | 3.6 Technical data

Electricity supply variant with a rated voltage of 110V

Alternating voltage 110 V; ± 10% (99 V – 121 V) Nominal frequency 50/60 Hz Max. current 10A Permissible impedance 0.2 Ohms Cross-section of the power line Up to a max. 8 m long: 1.5 mm² (or

Design of the mains power input Nominal voltage 110 V, corresponding to

Power consumption of both power supply voltage variants

AWG14); the diameter must be greater if the line is any longer.

applicable national regulations [ANSI/ NFPA + UL for USA]

Power consumption when X-ray is being taken

Nominal long-term output < 25 W

490 W [in film mode] 280 W [in sensor mode]

Nominal values of X-ray radiation

High voltage generation DC (high frequency), 300kHz Anode voltage 60 / 70 kV± 10% Anode current 7mA ± 15% [in film mode] 4mA ± 15% [in

sensor mode] Exposure time accuracy ± 10% Minimum current-time-product 0.14 mAs [in film mode] 0.08 mAs [in

sensor mode] Maximum current-time-product 13.2 mAs [in film mode] 3.5 mAs [in sen‐

sor mode Nominal value of focal spot 0.7 mm [IEC 336:1982] Anode material Tungsten Total filtering > 2.5 mm Al / 70 kV [IEC 60 522:1999] Leakage radiation < 0.25 mGy/h [IEC407:1973] Pulse:break ratio for 70 kV and 7mA [electronically moni‐

tored]: One X-ray at 0.1s every 14s for

the first hour, followed by one X-ray at

0.1s every 60s.

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Instructions for use KaVo In eXam 3510 3 Product description | 3.6 Technical data

Thermal characteristic of the x-ray tube.

Thermal characteristic of the radiation generating system.

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Instructions for use KaVo In eXam 3510 3 Product description | 3.6 Technical data

Dimensions, mass

The focus lies at the intersection between the two axes that are identified by the focus marks.

Focus-skin distance [FSD] 200 mm or 300 mm [optional with

Exit X-ray radiation field <60mm; < 35 * 45 mm² with rectangular

Size of packaging ca. 420 x 420 x 1250 mm Weight, packaged with additional equip‐

ment "Reach" of the X-ray arm 1,518 mm [optional], 1,800 mm, 2,100

1.003.1576] For the proper and correct

operation of the device according to its

intended purpose, use of the transparent

cone is mandatory!

radiation field limitation, material no.

1.003.0341, < 27 * 37 mm² with radiation

field limitation, material no. 10037200

< 35 kg

mm [optional]

Nominal values of laser used

Laser type Laser diode Classification according to IEC 825-1 Laser class 2 / < 1mW Wavelength 650 nm

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Instructions for use KaVo In eXam 3510 3 Product description | 3.6 Technical data

3.6.1 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 with 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 In 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 In eXam is suitable for use in all de‐

vices, 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 In eXam is suitable for use in all de‐

vices, 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 In eXam is suitable for use in all de‐

vices, 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.

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Instructions for use KaVo In eXam 3510 3 Product description | 3.6 Technical data

Guidelines and manufacturer's declaration - electromagnetic stability

In 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 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

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

Magnetic field at the supply frequency (50/60 Hz) in accor‐ dance with IEC 61000-4-8

+/- 6 kV Contact discharge +/- 8 kV Air discharge

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

+/- 1 kV Normal mode voltage +/- 2 kV Common mode voltage < 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

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

+/- 6 kV Contact discharge +/- 8 kV Air discharge

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

Floors should be made of wood or

concrete or be covered with cera‐

mic tiles. If the floor is covered with

a synthetic material versehen ist,

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.

The quality of the supply voltage

should be equivalent to that of a ty‐

pical business or hospital environ‐

ment. When the user of In eXam

demands continuing function of the

device even when the power supply

is interrupted, it is recommended

that In eXam be powered via an un‐

interruptible power supply or a bat‐

tery.

quency should correspond to the

typical values found in business

and hospital environments.

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Instructions for use KaVo In eXam 3510 3 Product description | 3.6 Technical data

Guidelines and manufacturer's declaration - electromagnetic stability

In 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 *

to 800 MHz

d = 2.3 * P for 800 MHz to 2.5 GHz

where P is the power rating of the

transmitter in watts (W) according

to information from the manufactur‐

er of the transmitter, and d is the

recommended safe distance in me‐

tres (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.

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

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 In eXam is being used exceeds the compliance level above, care should be taken with In eXam to ensure that it is functioning in accordance with regulations. If unusual performance features are no‐ ted, 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.

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Instructions for use KaVo In eXam 3510 3 Product description | 3.6 Technical data

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

In eXam is intended for use in an electromagnetic environment in which HF distur‐ bances are checked. The customer or user of In eXam can help to prevent electro‐ magnetic disturbances by complying with the minimum distance between portable and mobile HF telecommunications equipment (transmitters) and In eXam, depen‐ ding 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:

Power rating 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 di‐ stance 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 elec‐ tromagnetic waves is affected by absorption and reflection due to buildings, objects and people.

3.6.2 Standard conformity

See also: 2.5.1 Standard conformity, Page 18

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Instructions for use KaVo In eXam 3510 3 Product description | 3.7 Determination of the patient's X-ray exposure

3.7 Determination of the patient's X-ray exposure

3.7.1 Exposure diagram

The adjacent diagram directly shows what is known as the Kerma in mGy for the focus-skin distance (FSD) of 20 cm for the corresponding exposure time, which is displayed after exposure.

Note Exposure is measured in units of Gray. For dental applications, the conversion factor of the technical unit Gray to a dose in Sievert is 1.

Note If the focus-skin distance changes during exposure, the read amount needs to be corrected by the distance law.

Note Exposure by the read-off value relates to the area irradiated by the X-ray, and so it is necessary to record whether the normal radiation field of the cone of 60 mm diameter or the reduced radiation field of radiation field limitation facilityMat. no. 1.003.0341 orMat. no. 1.003.7200 was used.

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Instructions for use KaVo In eXam 3510 4 Operation | 4.1 Switch on machine

4 Operation

Note The description of how to operate the KaVo In eXam applies to both sensors and films.

Note A visible laser beam can be switched on to highlight the X-ray's central beam.

Avoidable exposure to radiation. An individual could fall ill as a result of receiving an excessive dose of X-ray.

CAUTION

▶ Provide patient protection measures (such as lead-lined collars) ▶ Take operator protection measures, such as applying the distance law, or using

screens during X-ray exposure

▶ Monitor the patient before and during X-ray exposure; if necessary, abort the

X-ray procedure and start again

CAUTION

Danger due to deviation from the defined focus-skin distance Not maintaining the specified focus-skin distance (i.e. skin surface too close to focus) can lead to unnecessary overexposure to radiation. ▶ Before using the machine, attach the transparent cone (which is detachable for

disinfection purposes) to make sure that the correct focus-skin distance is maintained during the X-ray prodedure.

4.1 Switch on machine

Requirement The unit's basic dose setting corresponds to the sensitivity class of the films or sensors being used.

▶ Switch on KaVo In eXam . ▶

If necessary, use the See also: 5 Setting default doses, film sensitivity and sensor sensitivity, Page 47

▶

If necessary, use the

operation.

The operating unit's display shows the X-ray image parameters (kV value, mA value, basic dose setting) and exposure time based on the selected area to be X-rayed. A green, light-emitting diode highlights the chosen area to be X-rayed.

button to adjust the basic dose setting.

button to specify the basic setting for film or sensor

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Instructions for use KaVo In eXam 3510 4 Operation | 4.2 Specifying the imaging parameters

4.2 Specifying the imaging parameters

▶ Choose the required kV.

Use the

want to take. ▶ Choose patient type.

Use the ▶ Choose area to be X-rayed.

Use the buttons assigned to the individual anatomical regions to choose the area

to be X-rayed. See also:

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

The specified X-ray time for the chosen X-ray image parameters is shown on the dispay.

button to select the 60kV or 70kV value according to the X-ray you

button to select the patient type (adult or child).

38/64

Instructions for use KaVo In eXam 3510 4 Operation | 4.3 Laser highlighting of central beam

4.3 Laser highlighting of central beam

A laser beam can be used to simulate the X-ray's central beam axis.

Laser beam (class 2) Looking directly into the laser beam can cause irritation or permanent changes.

CAUTION

▶ 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!

▶

Press the laser switch

central beam indicator (aiming laser).

(at the side of the X-ray tube head) to switch on the

39/64

Instructions for use KaVo In eXam 3510 4 Operation | 4.4 Positioning patients

4.4 Positioning patients

Note The following positioning examples are to be understood as principles. Appropriate positioning is described in the relevant literature.

The patient should preferably sit in a sagittal-vertical position.

For X-rays of the upper jaw, the no‐ se must be horizontally in line with the ear.

For X-rays of the lower jaw, the oc‐ clusion level must be horizontal.

40/64

Instructions for use KaVo In eXam 3510 4 Operation | 4.5 Position X-ray source

4.5 Position X-ray source

The scissor arm makes possible correct positioning of the generator for all types of X-rays. The cone assures that there is a distance of at least 20 cm between the focal spot and the skin.

Parallel technique/right-angle technique

When using the right-angle technique, KaVo recommends working with a handle and using the radiation field limitiation facility provided as standard:Mat. no. 1.003.0341

Dissecting angle technique

41/64

Instructions for use KaVo In eXam 3510

MAXILLA

MANDIBLE

INCISOR CUSPID PRAEMOLAR MOLAR

+40°

-15° -20° -10° -5°

+45° +30° +20°

4 Operation | 4.6 Positioning the image receiver

4.6 Positioning the image receiver

Dissecting angle technique

▶ Direct the image receivers and generators as shown here (with the beam per‐

pendicular to the bisecting line of the tooth/image receiver angle.)

42/64

Instructions for use KaVo In eXam 3510

MAXILLA

INCISOR CUSPID PRAEMOLAR MOLAR

MANDIBLE

4 Operation | 4.6 Positioning the image receiver

Parallel technique / right-angle technique

▶ Direct the image receiver and generator as shown here (with beam perpendi‐

cular to the film). Use a holding system here, if possible.

43/64

Instructions for use KaVo In eXam 3510

INCISOR MAXILLA

OKKLUSAL

MANDIBLE

MOLAR

60 ¡

65 ¡

90 ¡ 90 ¡

4 Operation | 4.6 Positioning the image receiver

Occlusion X-rays

Bitewing X-rays

44/64

Instructions for use KaVo In eXam 3510 4 Operation | 4.7 Take X-ray

4.7 Take X-ray

▶

Press the X-ray start button

indicator lamp goes out and the audio signal stops.

Note If the trigger button is released before the exposure ends, an operating error alarm sounds. It indicates that the transmission of the x-rays was prematurely terminated and the radiograph may be underexposed. The digital display alternately shows OP. ERROR and the time that was selected and not maintained. The alarm can be stopped by selecting another tooth on the control unit.

and keep depressed until the X-ray emission

45/64

Instructions for use KaVo In eXam 3510 4 Operation | 4.8 Finishing off activities

4.8 Finishing off activities

▶ Switch off the central beam indicator (pilot beam) with the button. ▶ Disinfect the cone that has come into contact with the patient.

46/64

Instructions for use KaVo In eXam 3510 5 Setting default doses, film sensitivity and sensor sensitivity | 5.1 Correction of the exposure time / dose

default setting

5 Setting default doses, film sensitivity and sensor sensitivity

Ionising radiation Possible consequence of receiving an excessive dose of X-ray.

CAUTION

▶ Depending on the indication and any country-specific regulations in force, use

the film type with the greatest possible sensitivity.

Requirement To obtain high-quality radiographs, great care is required when developing the film.

Note The film must be developed in accordance with the film manufacturer guidelines and developer equipment instructions.

5.1 Correction of the exposure time / dose default setting

The specified default dose for the machine refers to option "6" in the table below. If needed, adapt the basic dose setting with key

ITEM CORRECTION COEFFICIENT 0 - 73 % 0.27 1 - 67 % 0.33 2 - 59 % 0.41 3 - 49 % 0.51 4 - 36 % 0.64 5 - 20 % 0.80 6 0 1 7 + 25 % 1,25 8 + 56 % 1,56 9 + 95 % 1,95

47/64

Instructions for use KaVo In eXam 3510 5 Setting default doses, film sensitivity and sensor sensitivity | 5.2 Selection of the suitable basic dose

5.2 Selection of the suitable basic dose

5.2.1 With film

Requirement The

button is not active, meaning that the LED is not lit up and the display reads

"7mA".

The In eXam is set to the respective film type by using the keys to change the default dose to the value indicated in the following table.

Supplier Trade name Dose pre-selection with In

eXam AGFA Dentus M2 5 AGFA Dentus M4 3 AGFA Normal 6 DENTAL UNION Bleu Star 3 DUPONT Lightning fast 6 GEVAERT Dentus Ultra Rapid 6 KODAK Insight 2 KODAK Ekta Speed 3 KODAK Ekta Speed Plus 3 KODAK Ultra Speed 6 MINIMAX Intermediate 8 RINN Extra Fast 9 RINN Super Fast 6

5.2.2 With digital image receiver

Requirement Keep the

"4mA".

▶ Select adjustment of the preselected exposure according to the values indicated

in the corresponding instructions on operation of the digital image receiver

button is active, meaning that the LED is lit up and the display reads

48/64

Instructions for use KaVo In eXam 3510 5 Setting default doses, film sensitivity and sensor sensitivity | 5.3 Exposure time table

5.3 Exposure time table

The default doses used by the device are presented in the following sections. The specifications are based on a reference setting of level "6" and can be corre‐

spondingly adjusted using the default dose button

as mentioned above.

5.3.1 Default dose setting for X-rays taken using film

Requirement The

button is not active, meaning that the LED is not lit up and the display reads

"7mA".

Adult setting

Requirement The adult LED shines.

Program Tooth Bracket Expos‐

ure time in se‐ conds for film type 6 and 7 mA 70

kV Mandible Adult

41 42 31 32 -15 0.150 0.273

43 44 33 34 -20 0.150 0.273

45 46 35 36 -10 0.150 0.273

47 48 37 38 -5 0.178 0.323

Expos‐ ure time in se‐ conds for film type 6 and 7 mA 60 kV

49/64

Instructions for use KaVo In eXam 3510 5 Setting default doses, film sensitivity and sensor sensitivity | 5.3 Exposure time table

Program Tooth Bracket Expos‐

ure time

in se‐

conds for

film type

6 and 7

mA 70

kV Maxilla Adult

12 11 21 22 +40 0.178 0.323

13 14 23 24 +45 0.178 0.323

15 16 25 26 +30 0.232 0.423

17 18 27 28 +20 0.260 0.472

Expos‐ ure time in se‐ conds for film type 6 and 7 mA 60 kV

BITE‐ WING

OCCLU‐ SAL

Canines/ incisors

Molars - 0.178 0.323

Mandible or maxil‐ la

- 0.150 0.273

- 0.530 0.964

50/64

Instructions for use KaVo In eXam 3510 5 Setting default doses, film sensitivity and sensor sensitivity | 5.3 Exposure time table

Child setting

Requirement The child LED shines.

Program Tooth Bracket Expos‐

ure time

in se‐

conds for

film type

6 and 7

mA 70

kV Mandible Child

81 82 71 72 -15 0.075 0.137

83 73 -20 0.075 0.137

84 74 -20 0.075 0.137

85 75 -10 0.089 0.162

Expos‐ ure time in se‐ conds for film type 6 and 7 mA 60 kV

Maxilla Child

51 52 61 62 +40 0.089 0.162

53 63 +45 0.089 0.162

54 64 +45 0.116 0.211

55 65 +30 0.130 0.236

51/64

Instructions for use KaVo In eXam 3510 5 Setting default doses, film sensitivity and sensor sensitivity | 5.3 Exposure time table

Program Tooth Bracket Expos‐

ure time

in se‐

conds for

film type

6 and 7

mA 70

kV BITE‐ WING

OCCLU‐ SAL

Canines/ incisors

Molars - 0.089 0.162

Mandible or maxil‐ la

- 0.075 0.137

- 0.265 0.482

Expos‐ ure time in se‐ conds for film type 6 and 7 mA 60 kV

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

Requirement Keep the

"4mA".

button is active, meaning that the LED is lit up and the display reads

Adult setting

Requirement The adult LED shines.

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Instructions for use KaVo In eXam 3510 5 Setting default doses, film sensitivity and sensor sensitivity | 5.3 Exposure time table

Program Tooth Bracket Expos‐

ure time

in se‐

conds for

film type

6 and 4

mA 70

kV Mandible Adult

41 42 31 32 -15 0.088 0.159

43 44 33 34 -20 0.088 0.159

45 46 35 36 -10 0.088 0.159

47 48 37 38 -5 0.104 0.188

Expos‐ ure time in se‐ conds for film type 6 and 4 mA 60 kV

Maxilla Adult

BITE‐ WING

OCCLU‐ SAL

12 11 21 22 +40 0.104 0.188

13 14 23 24 +45 0.104 0.188

15 16 25 26 +30 0.136 0.247

17 18 27 28 +20 0.151 0.275

Canines/ incisors

Molars - 0.104 0.188

Mandible or maxil‐ la

- 0.088 0.159

- 0.245 0.445

53/64

Instructions for use KaVo In eXam 3510 5 Setting default doses, film sensitivity and sensor sensitivity | 5.3 Exposure time table

Child setting

Requirement The child LED shines.

Program Tooth Bracket Expos‐

ure time

in se‐

conds for

film type

6 and 4

mA 70

kV Mandible Child

81 82 71 72 -15 0.044 0.080

83 73 -20 0.044 0.080

84 74 -20 0.044 0.080

85 75 -10 0.052 0.094

Expos‐ ure time in se‐ conds for film type 6 and 4 mA 60 kV

Maxilla Child

51 52 61 62 +40 0.052 0.094

53 63 +45 0.052 0.094

54 64 +45 0.068 0.123

55 65 +30 0.076 0.138

54/64

Instructions for use KaVo In eXam 3510 5 Setting default doses, film sensitivity and sensor sensitivity | 5.3 Exposure time table

Program Tooth Bracket Expos‐

ure time

in se‐

conds for

film type

6 and 4

mA 70

kV BITE‐ WING

OCCLU‐ SAL

Canines/ incisors

Molars - 0.052 0.094

Mandible or maxil‐ la

- 0.044 0.080

- 0.122 0.222

Expos‐ ure time in se‐ conds for film type 6 and 4 mA 60 kV

55/64

Instructions for use KaVo In eXam 3510 6 Preparation methods DIN EN ISO 17664 | 6.1 Cleaning and disinfection

6 Preparation methods DIN EN ISO 17664

6.1 Cleaning and disinfection

Damage from improper cleaning and disinfection The use of unsuitable cleansers and disinfectants can impair the function or da‐

CAUTION

mage the device. ▶ Only clean the outer surfaces! ▶ Only use a soft cloth and mild cleaning solution! ▶ Do not use any solvents or aggressive chemicals!

Damage caused by liquid on the inside of the equipment If cleaning and disinfection agents are improperly used, liquid can access the inside of the equipment and result in functional impairment or even destruction. ▶ Exercise care that no cleaning or disinfiection fluid enters the inside of the

equipment.

The unit's transparent cone can be removed for easier cleaning and disinfection. All other surfaces of the unit can be wiped or disinfected with a damp cloth.

Note The In eXam unit does not include any parts requiring sterilisation as part of their intended use.

6.1.1 Cleaning

All external surfaces of the KaVo In eXam can be cleaned with a soft cloth and a mild cleaning fluid.

Clean the mirror(s)

Note The mirror is part of the internal filtering of the unit and must not be removed or altered. If the mirror is damaged, stop using the unit until it has been inpsected and repaired.

Kavo In eXam 3510 User Manual

Specifications and Main Features

Frequently Asked Questions

User Manual

Contents

Warning symbol