CEREC AC Operating Instructions for Acquisition unit Sept 2017

Table of contents

Dentsply Sirona Operating Instructions for the Acquisition Unit

Table of contents 1 2

3

4

5

2

Dear Customer, ...

5

1.1

Contact information ...

5

General data...

6

2.1

Structure of the document ... 2.1.1 Identification of the danger levels... 2.1.2 Formats and symbols used ...

6 6 7

2.2

Battery warranty ...

7

2.3

Legend ...

8

General description ...

10

3.1

Certification ...

10

3.2

Intended use...

10

3.3

Further use of Sirona Dental CAD/CAM System...

11

Safety ...

12

4.1

Basic safety information ... 4.1.1 Prerequisites ... 4.1.2 Connecting the unit ... 4.1.3 General safety information ... 4.1.4 Movement and stability of the unit... 4.1.5 Maintenance and repair... 4.1.6 Modifications to the product ... 4.1.7 Accessories ... 4.1.7.1 Included accessories ...

12 12 12 13 13 14 14 14 14

4.2

Safety labels...

15

4.3

Electrostatic charge... 4.3.1 ESD warning labels ... 4.3.2 ESD protective measures... 4.3.3 About the physics of electrostatic charges ...

17 17 17 18

4.4

Wireless phone interference with equipment ...

19

4.5

Integration in a network or connection to a modem ...

19

Technical information ...

20

5.1

Technical description...

20

5.2

Technical data ...

22

5.3

Electromagnetic compatibility... 5.3.1 Electromagnetic emission ... 5.3.2 Interference immunity... 5.3.3 Working clearances...

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Table of contents

Operating Instructions for the Acquisition Unit

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7

8

Installation and startup ...

27

6.1

Transport and unpacking...

27

6.2

Disposal of packaging materials...

27

6.3

Scope of supply...

27

6.4

Initial startup ... 6.4.1 Controls and functional elements ... 6.4.2 Operating state LED... 6.4.3 Plug connections ... 6.4.4 Insert battery (optional) ... 6.4.5 Using a trackball... 6.4.6 Changing from right-handed to left-handed operation... 6.4.7 Switching the units on ... 6.4.8 Switching the units off ...

28 28 31 31 32 33 33 33 35

6.5

Battery-backed operation (optional) ...

36

Operation...

39

7.1

Camera warm-up time...

39

7.2

Adjusting the CEREC Omnicam...

39

7.3

Taking acquisitions with the CEREC Omnicam ...

40

7.4

Directing the camera ... 7.4.1 Occlusal scan ... 7.4.2 Buccal scan ... 7.4.3 Lingual scan ... 7.4.4 Approximal surface scan ... 7.4.5 Buccal registration... 7.4.6 Scan procedure for the color analysis ... 7.4.7 Scanning the quadrant and jaw... 7.4.8 Completing measurements ...

41 42 42 43 43 44 44 44 47

7.5

Software for the CEREC Omnicam ... 7.5.1 Cut out model areas ...

48 48

Maintenance ...

49

8.1

49 49 49 50 50 51 51 52 52

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Care, cleaning, disinfection and sterilization ... 8.1.1 Cleaning and disinfection agents ... 8.1.2 Monitor screen... 8.1.3 Non-critical surfaces excluding monitor screen... 8.1.4 Trackball holder... 8.1.5 CEREC Omnicam ... 8.1.5.1 General information ... 8.1.5.2 Components of the Omnicam... 8.1.5.3 Removing the mirror sleeve...

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Table of contents

Dentsply Sirona Operating Instructions for the Acquisition Unit

8.1.5.4 8.1.5.5 8.1.5.6 8.1.5.7 8.1.5.8 8.1.5.9

9 10

11

4

Refitting the mirror sleeve ... Mirror sleeve reprocessing overview... Pre-cleaning of the mirror sleeve ... Disinfecting the camera body and mirror sleeve ... High-level disinfection of the mirror sleeve (with HLD Set) High-level disinfection of the mirror sleeve (without HLD Set) 8.1.5.10 Dry heat sterilization of the mirror sleeve ... 8.1.5.11 Use of CEREC Omnicam Disposable Sleeves ...

52 53 53 54 54 58

8.2

Calibrating CEREC Omnicam ...

62

8.3

Color calibration ...

64

8.4

Replacing the main fuse...

67

8.5

Charge battery (optional) ...

68

8.6

Replace battery (optional) ...

69

Disposal...

70

9.1

Disposal of the storage battery pack ...

71

PC Diagnostic Tool...

72

10.1

Checking the BIOS configuration (only V2.2.1 - V2.2.3) ...

72

10.2

Start diagnostic tool...

73

10.3

Test procedure ... 10.3.1 Customer Diagnostics ... 10.3.2 Technician Diagnostics ... 10.3.3 Sirona Windows Diagnostics...

74 74 76 78

10.4

Troubleshooting ... 10.4.1 Customer Diagnostics & Technician Diagnostics... 10.4.2 Sirona Windows Diagnostics...

80 80 83

Appendix ...

84

11.1

DVD playback ...

84

11.2

Making backup copies... 11.2.1 Creating (burning) a CD ...

84 84

11.3

Seal on PC slide-in module...

85

11.4

Windows Update ...

85

Index...

86

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1 Dear Customer,

Operating Instructions for the Acquisition Unit

1 Dear Customer,

Thank you for purchasing your CEREC AC® Connect from Sirona.

This unit enables you to create digital exposures and to transmit these to your dental laboratory. Improper use and handling can create hazards and cause damage. Please read and follow these operating instructions carefully and Always keep them within easy reach. To prevent personal injury or material damage, it is important to observe all safety information. Your Sirona Connect team

1.1 Contact information Customer service center

For technical questions, use the contact form on the internet at the following address: http://srvcontact.sirona.com

Manufacturer's address Sirona Dental Systems GmbH Fabrikstrasse 31 64625 Bensheim Germany Tel.: +49 (0) 6251/16-0 Fax: +49 (0) 6251/16-2591 e-Mail: [email protected] www.dentsplysirona.com

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2 General data

Dentsply Sirona

2.1 Structure of the document

Operating Instructions for the Acquisition Unit

2 General data

Please read this document completely and follow the instructions exactly. You should always keep it within reach. Original language of the present document: German.

2.1 Structure of the document 2.1.1

Identification of the danger levels To prevent personal injury and material damage, please observe the warning and safety information provided in these operating instructions. Such information is highlighted as follows:

DANGER An imminent danger that could result in serious bodily injury or death.

WARNING A possibly dangerous situation that could result in serious bodily injury or death.

CAUTION A possibly dangerous situation that could result in slight bodily injury.

NOTICE A possibly harmful situation which could lead to damage of the product or an object in its environment.

IMPORTANT Application instructions and other important information. Tip: Information for simplifying work.

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Operating Instructions for the Acquisition Unit

2.1.2

Formats and symbols used The formats and symbols used in this document have the following meaning: Prerequisite

Prompts you to do something.

1. First action step 2. Second action step or ➢

Alternative action

Result ➢ Individual action step See “Formats and symbols used [ → 7]”

Identifies a reference to another text passage and specifies its page number.

● List

Designates a list.

“Command / menu item”

Indicates commands, menu items or quotations.

2.2 Battery warranty The battery is subject to wear and the warranty period of 6 months therefore deviates from the period specified for the entire device.

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2.3 Legend

Operating Instructions for the Acquisition Unit

2.3 Legend Year of manufacture

Safety labels Identifies labels/imprints on the unit (see Safety labels). Product disposal symbol (see "Disposal [ → 70]").

Storage battery pack disposal symbol (see "Disposal of the storage battery pack" [ → 71])

Storage battery pack recycling symbol (see "Disposal of the storage battery pack" [ → 71])

The Sirona Connect may contain an RF transmitter in the form of a WLAN card or a separate wireless module. Radio approval for Australia/New Zealand

Follow the operating instructions. To ensure safe operation of the unit, the user must follow the operating instructions.

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Operating Instructions for the Acquisition Unit

Symbols on the packaging Take note of the following symbols on the packaging: Top

Protect from moisture

Fragile; handle with care

Temperature during storage and transport

Relative humidity during storage and transport

Air pressure during storage and transport

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3 General description

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3.1 Certification

Operating Instructions for the Acquisition Unit

3 General description 3.1 Certification CE mark This product bears the CE mark in accordance with the provisions of Council Directive 93/42/EEC of June 14, 1993 concerning medical devices.

NOTICE CE mark for connected products Further products which are connected to this unit must also bear the CE mark.

Compliance Anyone creating or changing a medical electrical system through a combination with other devices in accordance with standard EN 60601-11:2001 based on 60601-1-1:2000 (specification for the safety of medical electrical systems)/UL 60601-1 Part 1: first edition 2003 is responsible for ensuring that the requirements of these standards are met to the full extent in order to ensure the safety of patients, operators and the environment.

3.2 Intended use

The Sirona Dental CAD/CAM System is intended for use in partially or fully edentulous mandibles and maxillae in support of single or multipleunit cement retained restorations. For the SSO 3.5 L and SBL 3.3 L titanium bases, the indication is restricted to the replacement of single lateral incisors in the maxilla and lateral and central incisors in the mandible. The system consists of three major parts: TiBase, inCoris mesostructure, and CAD/CAM software. Specifically, the inCoris mesostructure and TiBase components make up a two-piece abutment which is used in conjunction with endosseous dental implants to restore the function and aesthetics in the oral cavity. The inCoris mesostructure may also be used in conjunction with the Camlog Titanium base CAD/ CAM (types K2244.xxxx) (K083496) in the Camlog Implant System. The CAD/CAM software is intended to design and fabricate the inCoris mesostructure. The inCoris mesostructure and TiBase two-piece abutment is compatible with the following implant systems: ● Nobel Biocare Replace (K020646) ● Nobel Biocare Branemark (K022562) ● Friadent Xive (K013867) ● Biomet 3i Osseotite (K980549) ● Astra Tech Osseospeed (K091239) ● Zimmer Tapered Screw-Vent (K061410) ● Straumann SynOcta (K061176) ● Straumann Bone Level (K053088, K062129, K060958) ● Biomet 3i Certain (K014235, K061629) ● Nobel Biocare Active (K071370)

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Operating Instructions for the Acquisition Unit

CAUTION Small diameter implants and large angled abutments in the anterior region of the mouth due to possible failure of the implant system.

CAUTION Federal Law (USA) restricts the sale of this device to or on the order of a physician, dentist, or licensed practitioner.

3.3 Further use of Sirona Dental CAD/CAM System The Sirona Dental CAD/CAM System is also an optical impression system for computer assisted design and manufacturing (CAD/CAM) according to 21 CFR 872.3661.The system records the topographical characteristics of teeth, dental impressions, or stone models for use in the computer-assisted design and manufacturing of dental restorative prosthetic devices. Such devices are exempt from the premarket notification procedures.

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4 Safety

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4.1 Basic safety information

Operating Instructions for the Acquisition Unit

4 Safety 4.1 Basic safety information 4.1.1

Prerequisites NOTICE Important information on building installation The building installation must be performed by a qualified expert in compliance with the national regulations. DIN VDE 0100-710 applies in Germany.

NOTICE Restrictions regarding installation site The system is not intended for operation in areas subject to explosion hazards.

NOTICE Do not damage the unit! The unit can be damaged if opened improperly. It is expressly prohibited to open the unit with tools!

4.1.2

Connecting the unit Perform connection by following the directions given in the present operating instructions.

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Operating Instructions for the Acquisition Unit

4.1.3

General safety information CAUTION Do not damage the monitor DO NOT touch the LCD screen with sharp or pointed objects. If the LCD monitor is damaged (e.g. the glass screen is broken), prevent any leaking liquid from coming into contact with your skin, mucous membranes (eyes, mouth), or foodstuffs and be careful not to inhale any escaping vapors. Rinse any parts of your body or items of clothing already contaminated by the liquid with ample amounts of water and soap.

CAUTION Note on the prevention, recognition, and elimination of unintended electromagnetic effects: The CEREC AC acquisition unit is Class B equipment (classified according to CISPR 11, EN 60601-1-2: 2007 based on IEC 60601-12:2007 and A1:2004). This system may be operated in a residential area provided that it is used under the responsibility of a medical specialist.

NOTICE Install only approved software To prevent interference with the runtime reliability of the program, only approved software may be installed. ➢ Use the current version ≥ CEREC Connect software 4.x.

NOTICE Ventilation openings must not be obstructed.

4.1.4

Movement and stability of the unit NOTICE The unit can overturn or slip away For reasons of tilt stability, the unit must be pulled by its front handle when being moved. If you push the unit, obstacles on the floor could block its wheels, thus causing it to overturn. The two front wheels of the unit have brakes which can be locked to ensure secure positioning. If the unit is steeply inclined or standing on a slippery surface and lateral forces are acting on it, it may slide even though the wheel brakes are locked. ➢ Always make sure that the unit's footprint is a flat, nonskid surface.

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4.1 Basic safety information

Operating Instructions for the Acquisition Unit

4.1.5

Maintenance and repair As manufacturers of dental instruments and laboratory equipment, we can assume responsibility for the safety properties of the unit only if the following points are observed: ● The maintenance and repair of this unit may be performed only by Dentsply Sirona or by agencies authorized by Dentsply Sirona. ● Components which have failed and influence the safety of the unit must be replaced with original (OEM) spare parts. Please request a certificate whenever you have such work performed. It should include: ● The type and scope of work. ● Any changes made in the rated parameters or working range. ● Date, name of company and signature.

4.1.6

Modifications to the product Modifications to this product which may affect the safety of the operator, patients or third parties are prohibited by law!

4.1.7

Accessories In order to ensure product safety, this device may be operated only with original Dentsply Sirona accessories or third-party accessories expressly approved by Dentsply Sirona. The user is responsible for any damage resulting from the use of non-approved accessories.

4.1.7.1

Included accessories ● Storage battery pack, order no.: 61 87 582

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4 Safety

Operating Instructions for the Acquisition Unit

4.2 Safety labels Fuses

NOTICE Use ONLY fuses of the same type!

Plug connections of external interfaces

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4.2 Safety labels

Operating Instructions for the Acquisition Unit

CAUTION Additional devices connected to external interfaces must be tested according to the relevant standards, e.g.: EN 60601-1:1990 + A1:1993 + A2:1995 based on IEC 60601-1, EN 60950-1:2001 based on IEC 60950-1:2001, EN61010-1:2001 based on IEC 61010-1:2001, UL 60601-1 Part1: first edition 2003, UL 60950 third edition 2000, UL 3101-1 Part 1 first edition 1993). They must be installed outside of the patient area (a radius of 1.5m surrounding the patient).

CAUTION Low voltages are applied to the sockets for connecting external interfaces. ➢ Do not touch the pins of the connectors.

NOTICE The externally connected cables must not be subjected to pulling stress.

CAUTION In order to maintain electrical safety, the rear doors of the acquisition unit must be kept closed while it is in operation. The acquisition unit must not be operated inside of the patient area (within a radius of 1.5 m surrounding the patient) with the doors open.

Heater plate

A

CAUTION Risk of burns due to hot surface! ➢ Never touch the heater plate (A)!

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Operating Instructions for the Acquisition Unit

4.3 Electrostatic charge 4.3.1

ESD warning labels

ESD warning label

CAUTION Risk of injury or damage to components from electrostatic discharge For electrical components labeled with an ESD warning label, observe the following instructions. ➢ Apply the ESD protective measures. ➢ Do not touch connector pins or sockets without applying ESD protective measures first. ➢ Do not establish any connections between these connectors without applying ESD protective measures first.

4.3.2

ESD protective measures

ESD

ESD stands for ElectroStatic Discharge.

ESD protective measures

ESD protective measures include: ● Procedures for preventing electrostatic charge build-up (e.g. air conditioning, air moistening, conductive floor coverings and nonsynthetic clothing) ● Discharging the electrostatic charges of your own body on the frame of the UNIT, the protective ground wire or large metallic objects ● Connecting yourself to ground using a wrist band.

Training

We therefore recommend that all persons working with this system be instructed on the significance of this warning label. Furthermore, they also should receive training in the physics of electrostatic discharges which can occur in the practice and the destruction of electronic components which may result if such components are touched by electrostatically charged USERS. The content of this training is explained in the Chapter "About the physics of electrostatic charges" [ → 18].

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4.3 Electrostatic charge

Operating Instructions for the Acquisition Unit

4.3.3 What is an electrostatic charge?

About the physics of electrostatic charges An electrostatic charge is a voltage field on and in an object (e.g. a human body) which is protected against conductance to ground potential by a nonconductive layer (e.g. a shoe sole).

Formation of an electrostatic charge Electrostatic charges generally build up whenever two bodies are rubbed against each other, e.g. when walking (shoe soles against the floor) or driving a vehicle (tires against the street pavement).

Amount of charge

The amount of charge depends on several factors: Thus the charge is higher in an environment with low air humidity than in one with high air humidity; it is also higher with synthetic materials than with natural materials (clothing, floor coverings). Electrostatic discharge must be preceded by electrostatic charging. The following rule of thumb can be applied to assess the transient voltages resulting from an electrostatic discharge. An electrostatic discharge is: ● perceptible at 3,000 V or higher ● audible at 5,000 V or higher (cracking, crackling) ● visible at 10,000 V or higher (arc-over) The transient currents resulting from these discharges have a magnitude of 10 amperes. They are not hazardous for humans because they last for only several nanoseconds.

Background

Integrated circuits (logical circuits and microprocessors) are used to implement a wide variety of functions in dental/X-ray/CAD/CAM systems. The circuits must be miniaturized to a very high degree in order to include as many functions as possible on these chips. This leads to structure thicknesses as low as a few ten thousandths of a millimeter. It is obvious that integrated circuits which are connected to plugs leading outside of the unit via cables are sensitive to electrostatic discharge. Even voltages which are imperceptible to the user can cause breakdown of the structures, thus leading to a discharge current which melts the chip in the affected areas. Damage to individual integrated circuits may cause malfunction or failure of the system.

To prevent this from happening, the ESD warning label next to the plug warns of this hazard. ESD stands for ElectroStatic Discharge. Connector pins or sockets bearing ESD warning labels must not be touched or interconnected without ESD protective measures.

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Operating Instructions for the Acquisition Unit

4.4 Wireless phone interference with equipment The use of mobile wireless phones in practice or hospital environments must be prohibited to ensure safe operation of the unit.

4.5 Integration in a network or connection to a modem

NOTICE Observe the following installation regulations The following installation regulations apply to integration of the acquisition unit in a network or connection of the acquisition unit to a modem:

Network The acquisition unit may only be operated in a network if it is connected to a HUB/switch. The HUB/switch must: ● be located in the room where the acquisition unit is operated, permanently installed. ● be grounded via an additional ground wire. Cross-section of the protective ground wire

laid protected

2.5 mm2

laid unprotected

4 mm2

Modem At least one of the following specifications must be fulfilled in order to operate the acquisition unit on a modem: ● If a modem is connected, the acquisition unit may only be operated outside of the patient area (radius of 1.5 m surrounding the patient). ● An RS232 isolator compliant with EN 60 601-1-1 with a dielectric strength of at least 1.5 kV must be installed at the modem end in the RS232 connecting cable between the acquisition unit and the modem. 65 88 250 D3492 D3492.201.07.20.23

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5 Technical information

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5.1 Technical description

Operating Instructions for the Acquisition Unit

5 Technical information 5.1 Technical description CAD system for high-precision intraoral optical impressions ● High-resolution, heated oral camera (3D camera) with removable reflective sleeve (reflective sleeve sterilizable with hot air) ● Integrated image processing ● High processing power due to state-of-the-art processor ● Trackball ● Hand and foot controlled enter keys ● Wipe-disinfectable membrane keyboard ● Hard disk ● DVD-R(W)/CD-R(W) drive ● Ethernet port ● USB port ● 1 integrated loudspeaker

High-resolution 3D intraoral camera with control and image processing electronics ● Measuring technique:

Triangulation

● Light source:

White LED, unpolarized, visible spectral range

● Image acquisition:

Image control inside the camera

● Image data transfer:

Gigabit Ethernet Standard

Monitor ● 19" TFT LCD flat display, true color, resolution SXGA (1280 x 1024 pixels)

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